Fecal Microbiota Transplant (FMT) for Pouchitis
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|ClinicalTrials.gov Identifier: NCT02428361|
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pouchitis||Drug: Biologically active human fecal material, OpenBiome||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||May 28, 2015|
|Actual Primary Completion Date :||April 9, 2018|
|Actual Study Completion Date :||March 4, 2019|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428361
|United States, California|
|UCSF Division of Gastroenterology at Mount Zion|
|San Francisco, California, United States, 94143|