Clinical Trial: Fecal Microbiota Transplant (FMT) for Pouchitis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title:

Brief 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.

Detailed 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.

Number of Subjects:

This study will aim to enroll approximately 30 patients with pouchitis.

Eligibility Criteria for FMT Group:

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 Ileal Pouch-Anal Anastomosis (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.

All patients who have a pouch for Inflammatory Bowel Disease (IBD) will be evaluated in Gastroenterology clinic or Colorectal surgery clinic. Patients who are eligible for the study will be identified during these regularly scheduled clinic visits. Patients who express interest will be set up for a meeting with a clinical research coordinator who will go over the study in detail and will obtain informed consent.

Prior to the FMT procedure stool samples will be checked for ova and parasites, C. difficile toxin and fecal calprotectin. Serum tests will include erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Anti-nuclear antibodies (ANA), complete blood cell count, HIV, screening for Hepatitis A, B, C (hep A IgM, hep B surface antigen and antibody, Hep C antibody), and creatinine. Eight days before treatment, patients will take a 5 da
Sponsor: Najwa Elnachef

Current Primary Outcome: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome: Mucosal healing [ Time Frame: 6 months ]

repeat pouchoscopy to determine


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: April 17, 2015
Date Started: May 2015
Date Completion: May 2018
Last Updated: March 20, 2017
Last Verified: March 2017