Clinical Trial: Study of Sc-FOS for Pouchitis Prevention

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

Official Title: Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial

Brief Summary: The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year [ Time Frame: baseline, 1 year ]

In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (<7 points).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: July 16, 2014
Date Started: August 2014
Date Completion: August 2019
Last Updated: March 23, 2017
Last Verified: March 2017