Trial Outcomes & Findings for Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis (NCT NCT03594487)
NCT ID: NCT03594487
Last Updated: 2026-02-03
Results Overview
This includes the proportion of participants who completed the study protocol, including the completion of the study visits at baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and a safety follow-up through week 48.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
Baseline through week 48
Results posted on
2026-02-03
Participant Flow
Screening period
Participant milestones
| Measure |
Interventional FMT Treatment Arm
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
Subjects, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, subjects will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, subjects will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Subjects, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
|
Overall Study
COMPLETED
|
4
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=1 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration, and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
n=41 Participants
|
53 years
n=1581 Participants
|
43.8 years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
5 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=41 Participants
|
1 participants
n=1581 Participants
|
5 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline through week 48Population: All enrolled participants who received FMT completed the study protocol; however, the study was interrupted due to the COVID-19 pandemic and a hold on the source material, and was subsequently closed to further enrollment.
This includes the proportion of participants who completed the study protocol, including the completion of the study visits at baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and a safety follow-up through week 48.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=1 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Participants Who Complete the Study Protocol
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.Population: No samples were collected for the control participant at any of the time points ( Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks) as the study was interrupted due to COVID-19. We don't have data to report for the change in microbiota structure for the control participant, who did not receive an intervention. This data will also not be reported in the future (as it was not collected).
Engraftment: Change in fecal microbiota community structure at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, 12 weeks by 16S ribosomal RNA amplicon sequencing (as a measure of the diversity of fecal microbiota by detecting sequence variations). Comment on unit of measure: The Shannon Index is used to assess changes in fecal microbiota diversity, with higher values indicating greater microbial diversity. Changes in the Shannon index over time will reflect the impact of the intervention on gut microbial composition.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=4 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Fecal Microbiota
Participant 1
|
0.87 Shannon index
|
4.60 Shannon index
|
4.10 Shannon index
|
4.50 Shannon index
|
4.10 Shannon index
|
—
|
—
|
—
|
—
|
—
|
|
Change in Fecal Microbiota
Participant 2
|
1.10 Shannon index
|
5.78 Shannon index
|
5.70 Shannon index
|
5.80 Shannon index
|
5.85 Shannon index
|
—
|
—
|
—
|
—
|
—
|
|
Change in Fecal Microbiota
Participant 3
|
5.10 Shannon index
|
5.60 Shannon index
|
5.15 Shannon index
|
5.18 Shannon index
|
5.20 Shannon index
|
—
|
—
|
—
|
—
|
—
|
|
Change in Fecal Microbiota
Participant 4
|
2.35 Shannon index
|
3.90 Shannon index
|
3.85 Shannon index
|
3.95 Shannon index
|
3.80 Shannon index
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.Population: All participants were monitored for the number of treatment-emergent serious adverse events from baseline through week 12.
Treatment-emergent serious adverse events from baseline through week 12. The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale for adverse events used in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=5 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]
Interventional arm
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
—
|
—
|
—
|
—
|
—
|
|
Number of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]
Observational arm
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
0 number of events
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.Population: All participants were monitored for the number of treatment-emergent non-serious adverse events from baseline through week 12.
Treatment-emergent non-serious adverse events from baseline through week 12. The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale for adverse events used in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=5 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-Emergent Non-Serious Adverse Events [Safety and Tolerability]
Interventional arm
|
1 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
—
|
—
|
—
|
—
|
—
|
|
Number of Treatment-Emergent Non-Serious Adverse Events [Safety and Tolerability]
Observational arm
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
0 Number of events
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.Population: Plasma CD19+ cell counts were measured at Weeks 0, 2, 4, 8, and 12. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Plasma CD19+ B cell count will be measured as absolute cell counts (cells/uL) at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=4 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=2 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=3 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Plasma CD19+ B Cells in Interventional Arm [CD19: Cluster of Differentiation Antigen 19]
Participant 2
|
133 cells/uL
|
139 cells/uL
|
137 cells/uL
|
143 cells/uL
|
130 cells/uL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Plasma CD19+ B Cells in Interventional Arm [CD19: Cluster of Differentiation Antigen 19]
Participant 3
|
269 cells/uL
|
218 cells/uL
|
168 cells/uL
|
220 cells/uL
|
217 cells/uL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Plasma CD19+ B Cells in Interventional Arm [CD19: Cluster of Differentiation Antigen 19]
Participant 4
|
55 cells/uL
|
65 cells/uL
|
—
|
74 cells/uL
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Plasma CD19+ B Cells in Interventional Arm [CD19: Cluster of Differentiation Antigen 19]
Participant 1
|
210 cells/uL
|
276 cells/uL
|
—
|
204 cells/uL
|
245 cells/uL
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.Population: Plasma CD19+ cell counts were measured at Weeks 0, 2, 4, 8, and 12. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Plasma CD19+ B cell count will be measured as absolute cell counts (cells/uL) at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Plasma CD19+ B Cells in Observational Arm
|
198 cells/uL
|
—
|
195 cells/uL
|
214 cells/uL
|
178 cells/uL
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.Population: Serum immunoglobulin levels at Weeks 0, 2, 4, 8, and 12 were collected. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Serum Immunoglobulin levels of IgA will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=4 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=2 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Serum IgA Immunoglobulin Levels in Interventional Arm [IgA: Immunoglobulin A]
Participant 2
|
129 mg/dL
|
117 mg/dL
|
127 mg/dL
|
120 mg/dL
|
128 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgA Immunoglobulin Levels in Interventional Arm [IgA: Immunoglobulin A]
Participant 3
|
381 mg/dL
|
387 mg/dL
|
397 mg/dL
|
337 mg/dL
|
380 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgA Immunoglobulin Levels in Interventional Arm [IgA: Immunoglobulin A]
Participant 4
|
248 mg/dL
|
221 mg/dL
|
—
|
253 mg/dL
|
236 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgA Immunoglobulin Levels in Interventional Arm [IgA: Immunoglobulin A]
Participant 1
|
89 mg/dL
|
90 mg/dL
|
—
|
79 mg/dL
|
137 mg/dL
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, and 12 weeks.Population: Serum immunoglobulin levels at Weeks 0, 2, 4, 8, and 12 were collected. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Serum Immunoglobulin levels of IgA will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, and 12 weeks.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Serum IgA Immunoglobulin Levels in Observational Arm
|
—
|
—
|
647 mg/dL
|
589 mg/dL
|
579 mg/dL
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks.Population: Serum immunoglobulin levels at Weeks 0, 2, 4, 8, and 12 were collected. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Serum Immunoglobulin levels of IgM will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=4 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=2 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Serum IgM Immunoglobulin Levels in Interventional Arm [IgM: Immunoglobulin M]
Participant 1
|
110 mg/dL
|
111 mg/dL
|
—
|
99 mg/dL
|
112 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgM Immunoglobulin Levels in Interventional Arm [IgM: Immunoglobulin M]
Participant 2
|
110 mg/dL
|
103 mg/dL
|
114 mg/dL
|
118 mg/dL
|
115 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgM Immunoglobulin Levels in Interventional Arm [IgM: Immunoglobulin M]
Participant 3
|
77 mg/dL
|
79 mg/dL
|
82 mg/dL
|
69 mg/dL
|
81 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgM Immunoglobulin Levels in Interventional Arm [IgM: Immunoglobulin M]
Participant 4
|
285 mg/dL
|
260 mg/dL
|
—
|
290 mg/dL
|
274 mg/dL
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks.Population: Serum immunoglobulin levels at Weeks 0, 2, 4, 8, and 12 were collected. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Serum Immunoglobulin levels of IgM will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The percentage of change from baseline for each time point is also reported.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Serum IgM Immunoglobulin Levels in Observational Arm
|
—
|
—
|
135 mg/dL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeksPopulation: Serum immunoglobulin levels at Weeks 0, 2, 4, 8, and 12 were collected. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Serum Immunoglobulin levels of IgG will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=4 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=2 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Serum IgG Immunoglobulin Levels in Interventional Arm [IgG: Immunoglobulin G]
Participant 1
|
966 mg/dL
|
979 mg/dL
|
—
|
925 mg/dL
|
1630 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgG Immunoglobulin Levels in Interventional Arm [IgG: Immunoglobulin G]
Participant 2
|
1070 mg/dL
|
1020 mg/dL
|
966 mg/dL
|
1040 mg/dL
|
1100 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgG Immunoglobulin Levels in Interventional Arm [IgG: Immunoglobulin G]
Participant 3
|
1170 mg/dL
|
1250 mg/dL
|
1290 mg/dL
|
1130 mg/dL
|
1160 mg/dL
|
—
|
—
|
—
|
—
|
—
|
|
Change in Serum IgG Immunoglobulin Levels in Interventional Arm [IgG: Immunoglobulin G]
Participant 4
|
939 mg/dL
|
855 mg/dL
|
—
|
972 mg/dL
|
960 mg/dL
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeksPopulation: Serum immunoglobulin levels at Weeks 0, 2, 4, 8, and 12 were collected. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Serum Immunoglobulin levels of IgG will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=1 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Serum IgG Immunoglobulin Levels in Observational Arm
|
—
|
—
|
984 mg/dL
|
928 mg/dL
|
870 mg/dL
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-treatment visit and week 12.Population: After screening, participants undergo MRI at pre-treatment and at Week 12 to assess for any new T2/FLAIR lesions during the treatment period in both the interventional and observational arms.
The number of new or enlarging T2/FLAIR lesions will be counted at pre-treatment and week 12.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=5 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of New T2/FLAIR Lesions
Interventional arm
|
0 number of lesions
|
1 number of lesions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of New T2/FLAIR Lesions
Observational arm
|
0 number of lesions
|
0 number of lesions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At pre-treatment visit and week 12.Population: After screening, participants undergo MRI at pre-treatment and at Week 12 to assess for any new enhancing lesions in both the interventional and observational arms.
New treatment-emergent gadolinium-enhancing lesions on brain MRI.
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=5 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=5 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment-emergent Gadolinium Enhancing Lesions
Interventional arm
|
0 number of enhancing lesions
|
1 number of enhancing lesions
|
—
|
—
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—
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—
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—
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—
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—
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—
|
|
Treatment-emergent Gadolinium Enhancing Lesions
Observational arm
|
0 number of enhancing lesions
|
0 number of enhancing lesions
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to week 12Population: Participants were monitored for clinical relapse through week 12.
Clinical relapse through week 12 (treatment phase)
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=1 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Clinical Relapse
|
0 Number of clinical relapses
|
0 Number of clinical relapses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-screening, Screening, Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48Population: Participants who completed the treatment arm were assessed for changes in fecal microbiota using 16S ribosomal RNA sequencing. Per the study protocol, no FMT intervention was performed in participants from the observation arm; therefore, only participants in the interventional arm are included in this secondary outcome analysis. Some participants were not able to complete the visit due to the COVID-19 pandemic; therefore, the number of participants analyzed is 0.
Flow cytometric analysis of peripheral blood mononuclear cells (PBMC) from each participant and at each time point. T-regs were induced by stimulation of PBMCs with anti-CD3 and anti-CD28 antibodies in the presence of IL2 and TGFb. The percentage of T-regs before and after FMT was analyzed. FMT was performed during the baseline visit. \[CD3: cluster of differentiation 3, CD28: cluster of differentiation 28, IL2: interleukin2, TGFb: Transforming growth factor beta\]
Outcome measures
| Measure |
Interventional FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Observational Control Arm
n=2 Participants
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
Observational Control: Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
|
Change in Microbiota Structure at Week 4 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 8 in FMT Treatment Arm
n=2 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Change in Microbiota Structure at Week 12 in FMT Treatment Arm
n=4 Participants
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Average Percentage of Induced T-regs at 8 Weeks
n=3 Participants
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 12 Weeks
n=4 Participants
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 24 Weeks
n=3 Participants
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at 36 Weeks
n=3 Participants
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
Average Percentage of Induced T-regs at Week 48
n=3 Participants
Interventional arm:
After providing written informed consent, subjects underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects underwent the FMT procedure by an experienced gastroenterologist. Subjects returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Induced T-regulatory Cells
Participant 1
|
24.8 percentage of T-regs
|
21.1 percentage of T-regs
|
18.4 percentage of T-regs
|
23.8 percentage of T-regs
|
22.9 percentage of T-regs
|
17.2 percentage of T-regs
|
14.8 percentage of T-regs
|
20.7 percentage of T-regs
|
20.8 percentage of T-regs
|
13.2 percentage of T-regs
|
|
Percentage of Induced T-regulatory Cells
Participant 2
|
23.5 percentage of T-regs
|
25.1 percentage of T-regs
|
20.1 percentage of T-regs
|
25.3 percentage of T-regs
|
25.6 percentage of T-regs
|
21.4 percentage of T-regs
|
19.8 percentage of T-regs
|
18.2 percentage of T-regs
|
18.0 percentage of T-regs
|
16.6 percentage of T-regs
|
|
Percentage of Induced T-regulatory Cells
Participant 3
|
15.2 percentage of T-regs
|
—
|
24.5 percentage of T-regs
|
—
|
24.7 percentage of T-regs
|
22.4 percentage of T-regs
|
19.7 percentage of T-regs
|
19.7 percentage of T-regs
|
17.0 percentage of T-regs
|
15.6 percentage of T-regs
|
|
Percentage of Induced T-regulatory Cells
Participant 4
|
21.5 percentage of T-regs
|
—
|
14.5 percentage of T-regs
|
—
|
12.2 percentage of T-regs
|
—
|
12.4 percentage of T-regs
|
—
|
—
|
—
|
Adverse Events
Number of Events at 12 Weeks for Interventional FMT Treatment Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Number of Events at 36 Weeks for Interventional FMT Treatment Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Number of Events at 12 Weeks for Observational Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Number of Events at 12 Weeks for Interventional FMT Treatment Arm
n=4 participants at risk
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Number of Events at 36 Weeks for Interventional FMT Treatment Arm
n=4 participants at risk
After providing written informed consent, participants underwent screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants then initiated an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and try to optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants underwent the FMT procedure by an experienced gastroenterologist. Participants returned for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks.
FMP30 Donor Stool: FMP30 was manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool: Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30) obtained from the non-profit stool bank OpenBiome were administered via colonoscopy.
|
Number of Events at 12 Weeks for Observational Control Arm
n=1 participants at risk
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration, and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection.
The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Gastrointestinal disorders
Abdominal cramping / stomach upset
|
25.0%
1/4 • Number of events 2 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 2 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Gastrointestinal disorders
Diarrhea/Loose Stool
|
50.0%
2/4 • Number of events 2 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Gastrointestinal disorders
Dysgeusia
|
25.0%
1/4 • Number of events 2 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Gastrointestinal disorders
Heartburn
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
General disorders
Drowsiness
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
General disorders
Injection reaction to MS medication
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
General disorders
Neutropenia
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
General disorders
Temperature regulation (felt warmer or colder)
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Infections and infestations
Intertrigo
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 2 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Infections and infestations
Otitis Media
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Infections and infestations
Upper Respiratory Infection
|
50.0%
2/4 • Number of events 2 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Injury, poisoning and procedural complications
Spider bite
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Investigations
AST elevation (<2.5x normal)
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Investigations
Leukopenia
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Strain
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 2 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Nervous system disorders
Heat related worsening of neurologic symptoms (typical of MS)
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Nervous system disorders
Numbness / Tingling (transient)
|
50.0%
2/4 • Number of events 3 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Skin and subcutaneous tissue disorders
Scalp itch
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
|
Vascular disorders
Deep Vein Thrombosis
|
25.0%
1/4 • Number of events 1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/4 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
0.00%
0/1 • 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.
The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale used for AEs in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
|
Additional Information
Dr. Jeffrey Gelfand, MD, MAS
University of California, San Francisco
Phone: 415-353-2069
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place