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 ]
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