CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Fecal microbiota transplantation +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03378921
NCT03378921Phase 2Completed
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Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis

Helsinki University Central Hospital·interventional·Posted Dec 20, 2017·Updated Apr 28, 2021

In Brief

A Phase 2 clinical trial evaluating Fecal microbiota transplantation and Placebo for Pouchitis and Ulcerative Colitis. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPouchitis, Ulcerative Colitis
CountriesFinland
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 20, 2017
Enrollment StartFeb 27, 2018
Primary CompletionSep 25, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.5 years ago

Interventions

Fecal microbiota transplantationbiological

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.

Placebobiological

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.