Phase 2
Completed N=26
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
Pouchitis · Ulcerative Colitis
Source: ClinicalTrials.gov NCT03378921 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Clinical Remission — 4; 5 Participants — p=0.183
Summary
The aim of our study is to investigate the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested donor and 13 patients in the control group receive their own feces.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Remission |
4; 5 | 0.183 |
| SECONDARY Evaluation of the Changes in Gut Microbiota |
— | — |
Eligibility Criteria
Inclusion Criteria
- Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis
- Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6 months prior to FMT
- Need of frequent or continuous use of antibiotics or probiotics because of the chronic pouchitis
- Availability of consecutive fecal samples during one year
- Compliance to attend FMT and control pouchoscopy after 52 weeks
Exclusion Criteria
- Unable to provide informed consent
- Use of immunosuppressive or biological medication
- Use of corticosteroids
- Acute pouchitis
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03378921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.