Fecal Microbiota Transplant for Inflammatory Bowel Disease

• Status: Completed
• Trial end date: 2017-11-04
• Target enrollment: 0
• Participant gender: All

Summary

Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.

This is a prospective, open label pilot study in which patients with symptoms of Inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.

The investigators hypothesize that FMT is a safe and effective treatment for patients with inflammatory bowel disease. The aims are:

1. To determine if symptoms of inflammatory bowel disease can be successfully treated by Fecal Microbial Transplantation.

2. To determine if endoscopic appearance of colon or ileum improves following treatment by Fecal Microbial Transplantation.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco

Criteria

Inclusion Criteria:

• Patients with history of Ulcerative Colitis confirmed by endoscopy and pathology and with a Mayo clinic ulcerative colitits disease activity score of 6 or greater.

• Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.

Exclusion Criteria:

• Female patients who are pregnant.

• Patients with severe immunosuppression (absolute neutrophil count < 1000 or CD4 count <200).

• Patients with untreated enteric infection.

• Patients with colon cancer or dysplasia