NCT02390726

Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis, Active Moderate

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant
BIOLOGICAL	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• Completion: 2018-09-01
• First posted: 2015-03-17
• Last updated: 2018-07-09

Locations

1 site across 1 country: United States