drugset / Trial / NCT02782325
Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)
Phase 1/2
Terminated
6 enrolled
University of North Carolina, Chapel Hill
Crohn's and Colitis Foundation · collabOpenBiome · collabThe Broad Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in which 50% of the patients will receive FMT and 50% will receive a placebo FMT. Additionally the trial offers an open label extension period.
Timeline
- Start
- 2017-06-01
- Primary completion
- 2018-12-03
- Completion
- 2018-12-03
Outcome
Outcome not reported
Stopped: “Due low efficacy of FMT in interim analysis.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fecal Microbiome Transplantation | Unknown | — | Other |