Trial Outcomes & Findings for Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis (NCT NCT02330653)
NCT ID: NCT02330653
Last Updated: 2023-10-16
Results Overview
Number of participants with FMT-related adverse events grade 2 or above experienced in each arm.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
At 8 weeks after start of FMT up to 6 months post treatment, an average of 10 months
Results posted on
2023-10-16
Participant Flow
Participant milestones
| Measure |
Fecal Microbiota Transplant (FMT)
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
Baseline characteristics by cohort
| Measure |
Fecal Microbiota Transplant (FMT)
n=8 Participants
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=5 Participants
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 8 weeks after start of FMT up to 6 months post treatment, an average of 10 monthsPopulation: Participants who received FMT or placebo, completed the study, and follow up data is available.
Number of participants with FMT-related adverse events grade 2 or above experienced in each arm.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT)
n=8 Participants
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=5 Participants
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
Fecal Microbiota Transplant (FMT) Ulcerative Colitis
Participants with a diagnosis of Ulcerative Colitis that received induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
|
Placebo Ulcerative Colitis
Participants with a diagnosis of Ulcerative Colitis that received induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
|
|---|---|---|---|---|
|
1. Safety and Tolerability of Universal Donor FMT Compared to Placebo: FMT-related Adverse Events Grade 2 or Above
|
4 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At all intermediate timepoints until 6 month follow up post intervention, an average of 10 monthsPopulation: Participants who received FMT or placebo, completed the study, and follow up data is available.
Remission as defined by a PUCAI score of less than 9 (for UC) or by a PCDAI score of less than 10 (for CD)
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT)
n=1 Participants
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=2 Participants
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
Fecal Microbiota Transplant (FMT) Ulcerative Colitis
n=5 Participants
Participants with a diagnosis of Ulcerative Colitis that received induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
|
Placebo Ulcerative Colitis
n=3 Participants
Participants with a diagnosis of Ulcerative Colitis that received induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
|
|---|---|---|---|---|
|
Remission of Disease
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At End of Treatment (8 weeks) and at 6 month post treatmentPopulation: Participants who received FMT or placebo, completed the study, and follow up data is available.
Improvement in inflammatory biomarkers (stool calprotectin, serum ESR, CRP, albumin, hematocrit) compared to baseline.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT)
n=6 Participants
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=5 Participants
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
Fecal Microbiota Transplant (FMT) Ulcerative Colitis
n=4 Participants
Participants with a diagnosis of Ulcerative Colitis that received induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
|
Placebo Ulcerative Colitis
Participants with a diagnosis of Ulcerative Colitis that received induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
|
|---|---|---|---|---|
|
Improvement in Inflammatory Biomarkers
Decrease in Fecal Calprotectin at 8 weeks
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Improvement in Inflammatory Biomarkers
Decrease in Fecal Calprotectin at 6 months
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Improvement in Inflammatory Biomarkers
Decrease in CRP at 8 weeks
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Improvement in Inflammatory Biomarkers
Decrease in CRP at 6 months
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Improvement in Inflammatory Biomarkers
Decrease in ESR at 8 weeks
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Improvement in Inflammatory Biomarkers
Decrease in ESR at 6 months
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: At two weeks and seven weeks post induction enemaPopulation: Participants who received FMT or placebo, completed the study, and follow up data is available.
We will assess changes in microbial composition and the extent of microbial engraftment from the donor in the recipient by comparing the similarity of the microbiomes at two weeks at seven weeks after the induction enema.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT)
n=6 Participants
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=4 Participants
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
Fecal Microbiota Transplant (FMT) Ulcerative Colitis
Participants with a diagnosis of Ulcerative Colitis that received induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
|
Placebo Ulcerative Colitis
Participants with a diagnosis of Ulcerative Colitis that received induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
|
|---|---|---|---|---|
|
Percentage of Donor Microbiome Present in Transplant Recipient
Engraftment at 2 weeks
|
74.8 percentage of donor microbiome present
Interval 33.3 to 90.1
|
41.8 percentage of donor microbiome present
Interval 26.2 to 64.9
|
—
|
—
|
|
Percentage of Donor Microbiome Present in Transplant Recipient
Engraftment at 7 weeks
|
68.3 percentage of donor microbiome present
Interval 7.34 to 91.5
|
47.9 percentage of donor microbiome present
Interval 2.8 to 84.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At 8 weeks after start of FMTPopulation: There were 1 CD and 5 UC participants in the FMT group that completed the study protocol and follow up. There were 2 CD and 3 UC participants that completed the Placebo and were eligible for 8 weeks of Open-Label FMT that completed the study protocol and follow up.
5a. For UC - Improvement of Pediatric Ulcerative Colitis Activity Index (PUCAI) by 20 points or more. Improvement in disease status as measured by improvement of PUCAI score by 20 points or more. 5b. For CD - Improvement of Pediatric Crohn's Disease Activity Index (PCDAI) by 12.5 points or more. Improvement of disease status as measured by improvement of PCDAI score by 12.5 points or more.
Outcome measures
| Measure |
Fecal Microbiota Transplant (FMT)
n=6 Participants
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=5 Participants
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
Fecal Microbiota Transplant (FMT) Ulcerative Colitis
Participants with a diagnosis of Ulcerative Colitis that received induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
|
Placebo Ulcerative Colitis
Participants with a diagnosis of Ulcerative Colitis that received induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
|
|---|---|---|---|---|
|
Number of Participants With Improvement in Disease Activity
UC Participants with improved disease scores as defined in outcome measure description
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Improvement in Disease Activity
CD Participants with improved disease scores as defined in outcome measure description
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Improvement in Disease Activity
UC and CD participants that did not meet improved disease activity score definitions
|
3 Participants
|
5 Participants
|
—
|
—
|
Adverse Events
Fecal Microbiota Transplant (FMT)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fecal Microbiota Transplant (FMT)
n=12 participants at risk
Adverse events are reported for participants during and after receiving FMT in either blinded or open-label treatment.
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=5 participants at risk
Adverse events are reported for participants during receipt of placebo treatment.
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
|---|---|---|
|
Cardiac disorders
Grade 3 Sinus Tachycardia
|
8.3%
1/12 • Number of events 1 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
0.00%
0/5 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
Gastrointestinal disorders
Grade 3 Colitis
|
16.7%
2/12 • Number of events 2 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
0.00%
0/5 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
Other adverse events
| Measure |
Fecal Microbiota Transplant (FMT)
n=12 participants at risk
Adverse events are reported for participants during and after receiving FMT in either blinded or open-label treatment.
Induction retention enema for the first week of treatment followed by once weekly administration of 15 capsules of study treatment (the equivalent of 7.5 grams of human stool) will be (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study treatment, study subjects on FMT who have shown improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks of once weekly FMT capsule administration.
Fecal Microbiota Transplant (FMT): The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
|
Placebo
n=5 participants at risk
Adverse events are reported for participants during receipt of placebo treatment.
Induction placebo enema for the first week of treatment followed by once weekly administration of 15 capsules of study placebo (administered within 60 minutes of thawing once weekly) for 7 weeks. After completing 8 weeks of blinded study placebo, study subjects on placebo who DO NOT demonstrate improvement will be given the option to receive open-label maintenance FMT weekly for an additional 8 weeks, beginning with a FMT induction enema followed by 7 weeks of weekly FMT capsule administration.
Placebo: Placebo administration will consist of both a placebo retention enema and placebo capsules.
|
|---|---|---|
|
Gastrointestinal disorders
Epiploic Appendagitis
|
8.3%
1/12 • Number of events 1 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
0.00%
0/5 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
Immune system disorders
Abnormal Lab Values
|
16.7%
2/12 • Number of events 12 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
0.00%
0/5 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
20.0%
1/5 • Number of events 1 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
Skin and subcutaneous tissue disorders
Eczema/Rash
|
16.7%
2/12 • Number of events 2 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
20.0%
1/5 • Number of events 1 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
8.3%
1/12 • Number of events 3 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
0.00%
0/5 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
General disorders
Non-Cardiac Chest Pain
|
16.7%
2/12 • Number of events 3 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
0.00%
0/5 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
8.3%
1/12 • Number of events 3 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
0.00%
0/5 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
|
Eye disorders
Eye Disorder/Blurred Vision
|
8.3%
1/12 • Number of events 2 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
20.0%
1/5 • Number of events 1 • The adverse event data was collected for 1 year post treatment, up to approximately 1 year and 4 months.
The definitions do not differ.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place