CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Fecal Microbiota Transplantationbiological
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/NCT02424175
NCT02424175Phase 2Completed

Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.

Brigham and Women's Hospital·interventional·Posted Apr 22, 2015·Updated Aug 28, 2019

In Brief

A Phase 2 clinical trial evaluating Fecal Microbiota Transplantation for Sclerosing Cholangitis. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This is an open-label single-arm pilot study to measure the safety, microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with Primary Sclerosing Cholangitis (PSC). The investigators will prospectively enroll 10 PSC patients Stage 1 and 2 who also have concurrent inflammatory bowel disease Donor Stool from one healthy donor will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 22, 2015
Enrollment StartFeb 1, 2016
Primary CompletionAug 30, 2017
Study CompletionMay 8, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.2 years ago

Interventions

Fecal Microbiota Transplantationbiological