Study of Sc-FOS for Pouchitis Prevention

Phase 1

Completed

• Conditions: Pouchitis
• Interventions: Drug: Short-Chain Fructooligosaccharide; Drug: Maltodextrin

• Registration Number: NCT02203955
• Lead Sponsor: Mayo Clinic

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Study Start: 2014-08
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-Chain Fructooligosaccharide	Short-Chain Fructooligosaccharide	4 chews (8.0 g scFOS) orally per day for 12 months
Maltodextrin	Maltodextrin	4 chews (maltodextrin) daily for 12 months

Primary Outcome Measures

Name	Time	Method
Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States