Fecal Microbiota Transplant (FMT) for Pouchitis
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:
- To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial Transplantation.
- To determine if endoscopic appearance of ileal pouch improves following treatment by Fecal Microbial Transplantation.
|Pouchitis||Drug: Biologically active human fecal material, OpenBiome||Early Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- Clinical improvement of pouchitis [ Time Frame: 4 weeks ]
In order to assess clinical improvement of pouchitis, patients will be scheduled for a 4 week post-FMT treatment clinic visit to ensure no adverse events have occurred and to assess patient symptoms.
Patients will also complete a survey both before and after treatment to evaluate the efficacy of FMT treatment.
- Mucosal healing [ Time Frame: 6 months ]repeat pouchoscopy to determine
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Pouchitis patients receiving FMT
Pouchitis patients receiving biologically active human fecal material sourced from OpenBiome.The physician will administer 250 mL of the fecal suspension in aliquots of 50-60 mL through the endoscope. The material will be delivered to the most proximal point of insertion.
Drug: Biologically active human fecal material, OpenBiome
Fecal microbiota transplant
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02428361
|United States, California|
|UCSF Division of Gastroenterology at Mount Zion|
|San Francisco, California, United States, 94143|