Trials / Completed
CompletedNCT02203955
Study of Sc-FOS for Pouchitis Prevention
Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Short-Chain Fructooligosaccharide | 4 chews (8.0 g scFOS) orally for 12 months |
| DRUG | Maltodextrin | 4 chews (maltodextrin) daily for 12 months |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2017-12-01
- Completion
- 2018-12-01
- First posted
- 2014-07-30
- Last updated
- 2020-02-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02203955. Inclusion in this directory is not an endorsement.