Study of Sc-FOS for Pouchitis Prevention

Completed · Phase 1

Conditions studied: Pouchitis

In brief

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.

Key facts

Study ID

NCT02203955

Run by

Mayo Clinic

People needed

13

Starts

2014-08-01

Expected to finish

2018-12-01

Last updated by the study team

2020-02-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65 years.
• History of ulcerative colitis
• Ileostomy closure after IPAA
• Ability to give appropriate consent

You may not qualify if…

• Crohn's disease.
• Perianal disease (including abscess, fissure, or stricture)
• Pregnancy
• Lactation
• Concurrent treatment for IBD or pouchitis

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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