Trial Outcomes & Findings for Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis (NCT NCT03378921)

NCT ID: NCT03378921

Last Updated: 2021-04-28

Results Overview

Clinical remission at week 52. All criteria need to be met: Pouchitis Disease Activity Index \<7 and no need for antibiotic treatment for pouchitis during the follow up

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: 52 weeks
• Results posted on: 2021-04-28

Participant Flow

Participant milestones

Measure	Donors Feces Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.	Patients Own Feces Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Donors Feces n=13 Participants Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.	Patients Own Feces n=13 Participants Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.	Total n=26 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 10.2 • n=13 Participants	45.5 years STANDARD_DEVIATION 11.7 • n=13 Participants	44.1 years STANDARD_DEVIATION 10.9 • n=26 Participants
Sex: Female, Male Female	6 Participants n=13 Participants	5 Participants n=13 Participants	11 Participants n=26 Participants
Sex: Female, Male Male	7 Participants n=13 Participants	8 Participants n=13 Participants	15 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Finland	13 participants n=13 Participants	13 participants n=13 Participants	26 participants n=26 Participants
Antibiotic use at time of study enrollment continuous use	5 Participants n=13 Participants	7 Participants n=13 Participants	12 Participants n=26 Participants
Antibiotic use at time of study enrollment repeated	8 Participants n=13 Participants	6 Participants n=13 Participants	14 Participants n=26 Participants
Probiotics	5 Participants n=13 Participants	6 Participants n=13 Participants	11 Participants n=26 Participants

PRIMARY outcome

Timeframe: 52 weeks

Clinical remission at week 52. All criteria need to be met: Pouchitis Disease Activity Index <7 and no need for antibiotic treatment for pouchitis during the follow up

Outcome measures

Measure	Donors Feces n=13 Participants Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.	Patients Own Feces n=13 Participants Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
Clinical Remission	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 54 weeks

Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.

Outcome measures

Outcome data not reported

Adverse Events

Donors Feces

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Patients Own Feces

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Donors Feces n=13 participants at risk Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Fecal microbiota transplantation: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.	Patients Own Feces n=13 participants at risk Fecal microbiota transplantation is performed by experienced endoscopists through flexible sigmoideoscopy into the afferent limb. The second FMT is installed via catheter into the pouch 4 weeks after the first FMT. Placebo: Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
General disorders fever	7.7% 1/13 • 52 weeks	7.7% 1/13 • 52 weeks
Gastrointestinal disorders abdominal pain	7.7% 1/13 • 52 weeks	0.00% 0/13 • 52 weeks
Gastrointestinal disorders fecal urgency	7.7% 1/13 • 52 weeks	0.00% 0/13 • 52 weeks

Additional Information

Dr. Essi Karjalainen

Department of Gastrointestinal surgery, Helsinki University Hospital

Phone: +358504621853

Email: essi.karjalainen@hus.fi

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place