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Study of Sc-FOS for Pouchitis Prevention

NCT02203955 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-02-24

No results posted yet for this study

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

  • Pouchitis

Interventions

DRUG

Short-Chain Fructooligosaccharide

4 chews (8.0 g scFOS) orally for 12 months

DRUG

Maltodextrin

4 chews (maltodextrin) daily for 12 months

Sponsors & Collaborators

Principal Investigators

  • Laura Raffals, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203955 on ClinicalTrials.gov