Fecal Microbiota Transplant for Inflammatory Bowel Disease

Completed · Early Phase 1

Conditions studied: Inflammatory Bowel Disease

In brief

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.

Key facts

Study ID

NCT02460705

Run by

University of California, San Francisco

People needed

59

Starts

2015-06-01

Expected to finish

2017-11-04

Last updated by the study team

2018-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UCSF Division of Gastroenterology at Mount Zion — San Francisco, California, United States

Full record on ClinicalTrials.gov

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