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OpenTrials
Completed

NCT Number: NCT02203955

Study of Sc-FOS for Pouchitis Prevention

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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Key information

Conditions

Pouchitis Digestive System Diseases Enteritis Gastroenteritis Gastrointestinal Diseases Ileal Diseases Ileitis Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Short-Chain Fructooligosaccharide

Drug

4 chews (8.0 g scFOS) orally for 12 months

Maltodextrin

Drug

4 chews (maltodextrin) daily for 12 months

Primary outcomes

  1. Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jul 30, 2014
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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