Study of Sc-FOS for Pouchitis Prevention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pouchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Short-Chain Fructooligosaccharide

4 chews (8.0 g scFOS) orally per day for 12 months

Group Type ACTIVE_COMPARATOR

Short-Chain Fructooligosaccharide

Intervention Type DRUG

4 chews (8.0 g scFOS) orally for 12 months

Maltodextrin

4 chews (maltodextrin) daily for 12 months

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DRUG

4 chews (maltodextrin) daily for 12 months

Interventions

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Short-Chain Fructooligosaccharide

4 chews (8.0 g scFOS) orally for 12 months

Intervention Type DRUG

Maltodextrin

4 chews (maltodextrin) daily for 12 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No