drugset / Trial / NCT02390726

Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

NCT02390726

Phase 0 Unknown 20 enrolled University of Vermont
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment. The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.

Timeline

Start
2015-12
Primary completion
2017-12
Completion
2018-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbiota Transplant Other / unclassified Intravenous

Indications