Fecal Microbiota Transplant (FMT) for Pouchitis

Completed · Early Phase 1

Conditions studied: Pouchitis

In brief

This is a prospective, open label pilot study in which patients with symptoms of acute or chronic pouchitis will receive FMT therapy delivered via pouchoscopy. The investigators hypothesize that FMT is a safe and effective treatment for patients with pouchitis. Our aims our: 1. To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial Transplantation. 2. To determine if endoscopic appearance of ileal pouch improves following treatment by Fecal Microbial Transplantation.

Key facts

Study ID

NCT02428361

Run by

Najwa Elnachef

People needed

19

Starts

2015-05-28

Expected to finish

2019-03-04

Last updated by the study team

2019-04-18

Who can join

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

You may qualify if…

• Both acute and chronic pouchitis will be eligible for treatment with FMT. Patients eligible for FMT will include:
• Patients with history of proctocolectomy with IPAA with pouchitis confirmed by endoscopy and pathology.
• 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 diagnosis of ileal Crohn's Disease.
• Patients with untreated enteric infection.
• Patients with fistulizing disease.
• Patients with gastroparesis or dysphagia will not be eligible for the arm of the study allowing for administration of weekly capsules

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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