Study of Sc-FOS for Pouchitis Prevention

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic

Criteria

Inclusion criteria:

1. Age 18-65 years.

2. History of ulcerative colitis

3. Ileostomy closure after IPAA

4. Ability to give appropriate consent

Exclusion Criteria:

1. Crohn's disease.

2. Perianal disease (including abscess, fissure, or stricture)

3. Pregnancy

4. Lactation

5. Concurrent treatment for IBD or pouchitis