Trial Outcomes & Findings for Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection (NCT NCT02403622)
NCT ID: NCT02403622
Last Updated: 2021-02-23
Results Overview
Determine the short-term safety of FMT for the prevention of further CDI recurrence. Short-term safety was measured by absence or presence of related serious adverse events
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
< 6 weeks post FMT
Results posted on
2021-02-23
Participant Flow
A total of 17 participants enrolled (signed consents) across four sites during the period between March 27, 2015 and October 4, 2017.
Two enrolled participants withdrew from the study prior to intervention.
Participant milestones
| Measure |
Intervention: Fecal Microbiota Preparation
Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.
Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor
Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
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|---|---|
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Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of FMT: OpenBiome Outcomes and Longitudinal Follow-up (STOOL) for Recurrent Clostridium Difficile Infection
Baseline characteristics by cohort
| Measure |
Intervention: Fecal Microbiota Preparation
n=17 Participants
Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.
Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor
Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
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|---|---|
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Age, Customized
Age · 18 to 35 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
Age · 35 to 55 years
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8 Participants
n=99 Participants
|
|
Age, Customized
Age · 55 to 75 years
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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17 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: < 6 weeks post FMTDetermine the short-term safety of FMT for the prevention of further CDI recurrence. Short-term safety was measured by absence or presence of related serious adverse events
Outcome measures
| Measure |
Intervention: Fecal Microbiota Preparation
n=15 Participants
Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.
Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor
Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
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|---|---|
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Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
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0 Participants
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PRIMARY outcome
Timeframe: > 6 weeks to 1 year post FMTPopulation: Data were not collected therefore could not be reported.
Determine the long-term safety of FMT for the prevention of further CDI recurrence
Outcome measures
Outcome data not reported
Adverse Events
Intervention: Fecal Microbiota Preparation
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention: Fecal Microbiota Preparation
n=15 participants at risk
Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.
Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor
Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
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|---|---|
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Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Endocrine disorders
Hyperthyroidism
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Infections and infestations
Urinary tract infection
|
13.3%
2/15 • Number of events 2 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Nervous system disorders
Embolic stroke
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Surgical and medical procedures
Gastrectomy
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Surgical and medical procedures
Pancreatectomy
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Surgical and medical procedures
Splenectomy
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
Other adverse events
| Measure |
Intervention: Fecal Microbiota Preparation
n=15 participants at risk
Open label single arm Dosage form: Screened human donor stool, sourced from human-derived microbes generated by healthy, screened donors.
Route of administration: either colonoscopic/sigmoidoscopic FMT or retention enema FMT Dosing Regimen: 250 mL x 1 dose. In the event of a clinical non-response, a repeat single 250 mL dose will occur from a different donor
Fecal Microbiota Preparation: Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
46.7%
7/15 • Number of events 8 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Bloating/Distention
|
13.3%
2/15 • Number of events 2 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Number of events 7 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
5/15 • Number of events 5 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Flatulence
|
40.0%
6/15 • Number of events 8 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Increase in bowel movements
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Gastrointestinal disorders
Incontinence
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Surgical and medical procedures
Knee Replacement
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Surgical and medical procedures
Laparoscopy
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Infections and infestations
UTI
|
33.3%
5/15 • Number of events 6 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Infections and infestations
CDI
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Vascular disorders
Stroke
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Weight gain
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Weight loss
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Thyrotoxicosis
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Metabolism and nutrition disorders
Graves' Disease
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
General disorders
Fatigue and malaise
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Immune system disorders
Allergies
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
|
Injury, poisoning and procedural complications
5th Metatarsal fracture
|
6.7%
1/15 • Number of events 1 • As outlined in the protocol, safety data were collected up to 12 months post-FMT. Due to study termination, not all participants were followed for the full 12 months, but instead an average of 11.7 months.
|
Additional Information
Majdi Osman, MD, MPH
Microbiome Health Research Institute
Phone: 6175752201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place