Fecal Microbiota Transplant (FMT) for Pouchitis

• Status: Completed
• Trial end date: 2019-03-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Najwa Elnachef

Criteria

Inclusion Criteria:

Both acute and chronic pouchitis will be eligible for treatment with FMT. Patients eligible for FMT will include:

1. Patients with history of proctocolectomy with IPAA with pouchitis confirmed by endoscopy and pathology.

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

Exclusion Criteria:

1. Female patients who are pregnant.

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

3. Patients with diagnosis of ileal Crohn's Disease.

4. Patients with untreated enteric infection.

5. Patients with fistulizing disease.

6. Patients with gastroparesis or dysphagia will not be eligible for the arm of the study allowing for administration of weekly capsules