Fecal Microbiota Transplant (FMT) for Pouchitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02428361|
Recruitment Status : Active, not recruiting
First Posted : April 28, 2015
Last Update Posted : October 26, 2017
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)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2018|
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|