Trial Outcomes & Findings for Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD) (NCT NCT03548051)
NCT ID: NCT03548051
Last Updated: 2022-05-02
Results Overview
New onset of related chronic medical conditions (NOCMCs) through 365 days after completing treatment for recurrent CDAD were reported. NOCMCs were defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study agent, that is expected to continue for at least 3 months and requires continued health care intervention.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Day 1 through Day 365
Results posted on
2022-05-02
Participant Flow
Participants were males and non-pregnant females 18 years of age or older who are diagnosed with recurrent CDAD. They were recruited from the community at large around the clinical sites. The enrollment period occurred between 11JAN2019 and 23JAN2020.
Participant milestones
| Measure |
FMPE Group
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally
A single dose of fecal microbial suspension contains 100 g of stool in 250 mL diluent, comprising 12.5% glycerol and 87.5% sterile normal saline buffer (0.9% NaCl).
|
FMPP Group
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally
The placebo microbiota preparation (FMPP) is formulated with 250 mL sterile Sodium Chloride (0.9%, USP), Glycerol (12.5%, USP), 8-12 drops brown food coloring (AmeriColor 204 or similar) and water.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
FMPE Group
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally
A single dose of fecal microbial suspension contains 100 g of stool in 250 mL diluent, comprising 12.5% glycerol and 87.5% sterile normal saline buffer (0.9% NaCl).
|
FMPP Group
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally
The placebo microbiota preparation (FMPP) is formulated with 250 mL sterile Sodium Chloride (0.9%, USP), Glycerol (12.5%, USP), 8-12 drops brown food coloring (AmeriColor 204 or similar) and water.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of FMT in Individuals With One or More Recurrences of Clostridium Difficile Associated Disease (CDAD)
Baseline characteristics by cohort
| Measure |
FMPE Group
n=6 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally
A single dose of fecal microbial suspension contains 100 g of stool in 250 mL diluent, comprising 12.5% glycerol and 87.5% sterile normal saline buffer (0.9% NaCl).
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally
The placebo microbiota preparation (FMPP) is formulated with 250 mL sterile Sodium Chloride (0.9%, USP), Glycerol (12.5%, USP), 8-12 drops brown food coloring (AmeriColor 204 or similar) and water.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
60.5 years
STANDARD_DEVIATION 15.1 • n=107 Participants
|
50.3 years
STANDARD_DEVIATION 15.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
BMI
|
22.92 kg/m^2
STANDARD_DEVIATION 5.17 • n=99 Participants
|
26.28 kg/m^2
STANDARD_DEVIATION 8.83 • n=107 Participants
|
24.41 kg/m^2
STANDARD_DEVIATION 6.76 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 365Population: The safety analysis population included all subjects who received the study treatment and had at least one post-treatment safety assessment.
New onset of related chronic medical conditions (NOCMCs) through 365 days after completing treatment for recurrent CDAD were reported. NOCMCs were defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study agent, that is expected to continue for at least 3 months and requires continued health care intervention.
Outcome measures
| Measure |
FMPE Group
n=6 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Number of Participants With a New Onset of Related Chronic Medical Condition After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 365Population: The safety analysis population included all subjects who received the study treatment and had at least one post-treatment safety assessment.
SAEs included any adverse event or suspected adverse reaction which, in the view of the investigator or sponsor, resulted in any of the following: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a congenital anomaly/birth defect, persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life function.
Outcome measures
| Measure |
FMPE Group
n=6 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Number of Participants With a Serious Adverse Event (SAE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 30Population: The safety analysis population included all subjects who received the study treatment and had at least one post-treatment safety assessment.
Adverse events were defined as any noxious, pathologic, or unintended change in anatomic, physiologic, or metabolic functions, as indicated by physical signs, symptoms, and/or laboratory changes occurring in any phase of the clinical trial, regardless of their relationship to investigational product.
Outcome measures
| Measure |
FMPE Group
n=6 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Number of Participants With an Adverse Event (AE) After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 365Population: The safety analysis population included all subjects who received the study treatment and had at least one post-treatment safety assessment.
Adverse Events of Special Interest were defined as newly acquired transmissible infectious agents or infectious diseases related to study product and the following agents: HIV type 1 and 2, Hepatitis A, B, C, Treponema pallidum, HTLV-1, -2, Cyclospora, Salmonella, Shigella, Campylobacter, E. coli 0157:H7, Shiga-toxin producing E. coli, Ova and enteric parasites including Isospora, Vancomycin-resistant Enterococcus (VRE), extended spectrum beta-lactamase (ESBL), carbapenemase producing gram-negative rods, methicillinresistant Staphylococcus aureus (MRSA), Helicobacter pylori, Rotavirus, Adenovirus, Norovirus, Vibrio, Giardia lamblia, Cryptosporidium, and Microsporidia.
Outcome measures
| Measure |
FMPE Group
n=6 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Number of Participants With Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI), After Completing Treatment for Recurrent Clostridium Difficile-Associated Diarrhea (CDAD)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 30Population: The Modified Intention-to-Treat (mITT) analysis population included all randomized subjects who received the study treatment and were followed through the Day 30 visit. Subjects who were not able to retain at least 50% of the enema within 1-3 hours, and either refused a second enema, or were not able to retain at least 50% of the second enema within 1-3 hours were excluded from this population.
Clinical response was defined as those subjects who have no recurrence of CDAD through Day 30 after completing treatment for recurrent CDAD. CDAD was defined as bowel movements as determined by \>=3 unformed stools (soft or watery) within 24 consecutive hours and a positive PCR test for Clostridium difficile.
Outcome measures
| Measure |
FMPE Group
n=5 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Proportion of Participants With Clinical Response (Defined as no Recurrence of Clostridium Difficile-Associated Diarrhea (CDAD))
|
0.80 proportion of participants
Interval 0.38 to 0.96
|
0.75 proportion of participants
Interval 0.3 to 0.95
|
SECONDARY outcome
Timeframe: Day 1 through Day 30Population: The Modified Intention-to-Treat (mITT) analysis population included all randomized subjects who received the study treatment and were followed through the Day 30 visit. Subjects who were not able to retain at least 50% of the enema within 1-3 hours, and either refused a second enema, or were not able to retain at least 50% of the second enema within 1-3 hours were excluded from this population.
Recurrence was defined as the re-establishment of diarrhea (frequency of passed unformed stools, \>=3 unformed stools within 24 consecutive hours) with a positive PCR test for C. difficile.
Outcome measures
| Measure |
FMPE Group
n=5 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Number of Recurrences of Clostridium Difficile-Associated Diarrhea (CDAD) After Completing Treatment for Recurrent CDAD
|
0.2 recurrence of CDAD
Standard Deviation 0.4
|
0.3 recurrence of CDAD
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The Modified Intention-to-Treat (mITT) analysis population included all randomized subjects who received the study treatment and were followed through the Day 30 visit. Subjects who were not able to retain at least 50% of the enema within 1-3 hours, and either refused a second enema, or were not able to retain at least 50% of the second enema within 1-3 hours were excluded from this population.
Recurrence was defined as the re-establishment of diarrhea (frequency of passed unformed stools, \>=3 unformed stools within 24 consecutive hours) with a positive PCR test for C. difficile.
Outcome measures
| Measure |
FMPE Group
n=5 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Number of Recurrences of Clostridium Difficile-Associated Diarrhea (CDAD) After Completing Treatment for Recurrent CDAD
|
0.2 recurrence of CDAD
Standard Deviation 0.4
|
0.3 recurrence of CDAD
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Day 1 through Day 60Population: The Modified Intention-to-Treat (mITT) analysis population included all randomized subjects who received the study treatment and were followed through the Day 30 visit. Subjects who were not able to retain at least 50% of the enema within 1-3 hours, and either refused a second enema, or were not able to retain at least 50% of the second enema within 1-3 hours were excluded from this population.
Sustained clinical response is defined as those subjects who responded by Day 30 with no recurrence of CDAD through Day 60 after randomization.
Outcome measures
| Measure |
FMPE Group
n=5 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Proportion of Participants With Sustained Clinical Response
|
0.80 proportion of participants
Interval 0.38 to 0.96
|
0.75 proportion of participants
Interval 0.3 to 0.95
|
SECONDARY outcome
Timeframe: Day 1 through Day 60 visit windows reported as Weeks 1 through 8, respectivelyPopulation: The Modified Intention-to-Treat (mITT) analysis population included all randomized subjects who received the study treatment and were followed through the Day 30 visit. Subjects who were not able to retain at least 50% of the enema within 1-3 hours, and either refused a second enema, or were not able to retain at least 50% of the second enema within 1-3 hours were excluded from this population.
The time (in weeks) until first CDAD recurrence was calculated as time from randomization to the end of the interval of ascertainment. Participants without a recurrence were censored at their last known contact date or their Day 60 visit, whichever occurred first.
Outcome measures
| Measure |
FMPE Group
n=5 Participants
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 Participants
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 1 at Risk
|
5 participants
|
4 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 1 with CDAD
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 1 Censored
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 2 at Risk
|
5 participants
|
4 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 2 with CDAD
|
1 participants
|
1 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 2 Censored
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 3 at Risk
|
4 participants
|
3 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 3 with CDAD
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 3 Censored
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 4 at Risk
|
4 participants
|
3 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 4 with CDAD
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 4 Censored
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 5 at Risk
|
4 participants
|
3 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 5 with CDAD
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 5 Censored
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 6 at Risk
|
4 participants
|
3 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 6 with CDAD
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 6 Censored
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 7 at Risk
|
4 participants
|
3 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 7 with CDAD
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 7 Censored
|
0 participants
|
1 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 8 at Risk
|
4 participants
|
2 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 8 with CDAD
|
0 participants
|
0 participants
|
|
Time to First Clostridium Difficile-Associated Diarrhea (CDAD) Reoccurrence (Using the Date of First Positive PCR Post-enema)
Week 8 Censored
|
4 participants
|
2 participants
|
Adverse Events
FMPE Group
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
FMPP Group
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
FMPE Group
n=6 participants at risk
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 participants at risk
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Infections and infestations
Clostridium difficile infection
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 3 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/6 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/6 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
Other adverse events
| Measure |
FMPE Group
n=6 participants at risk
100 g of thawed, processed stool diluted into 250 ml of saline and delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
FMPP Group
n=4 participants at risk
250 ml of saline delivered by retention enema given 1-3 hours after administering loperamide 4 mg orally.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Abdominal Distention
|
100.0%
6/6 • Number of events 38 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
75.0%
3/4 • Number of events 4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Abdominal Pain
|
100.0%
6/6 • Number of events 32 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 15 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
4/6 • Number of events 11 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
75.0%
3/4 • Number of events 14 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Flatulence
|
66.7%
4/6 • Number of events 23 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
50.0%
2/4 • Number of events 11 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 5 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
General disorders
Malaise
|
66.7%
4/6 • Number of events 22 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 2 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
50.0%
3/6 • Number of events 15 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Vascular disorders
Diastolic Hypertension
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Vascular disorders
Systolic Hypertension
|
0.00%
0/6 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
25.0%
1/4 • Number of events 4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Haemorrhoids
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Gastrointestinal disorders
Oesophagitis
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Investigations
Blood pressure Increased
|
16.7%
1/6 • Number of events 1 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 2 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
0.00%
0/4 • Solicited AEs were collected through 8 days after each enema. Non-serious AEs and abnormal clinical laboratory tests were collected from treatment initiation through 30 days after completing treatment for recurrent CDAD. SAEs, NOCMCs, AESIs, and new onset metabolic syndrome were collected from treatment initiation through 365 days after completing treatment for recurrent CDAD. All-cause mortality was assessed through 365 days after completing treatment for recurrent CDAD.
Solicited AEs included fever, chills, nausea, diarrhea, vomiting, constipation, abdominal cramps, abdominal Bloating, flatulence, malaise, fatigue and loss of appetite. Clinical laboratory tests included potassium, creatinine, liver function tests (ALT), hemoglobin, WBC, neutrophil count, platelets.
|
Additional Information
Nadine Rouphael
Hope Clinic of the Emory Vaccine Center
Phone: 404-377-3719
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60