Study of Sc-FOS for Pouchitis Prevention

February 20, 2020 updated by: Laura E. Raffals, M.D, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Short-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally per day for 12 months
Drug: Short-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally for 12 months
Placebo Comparator: Maltodextrin
4 chews (maltodextrin) daily for 12 months
Drug: Maltodextrin
4 chews (maltodextrin) daily for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Laura Raffals, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 20, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-001220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pouchitis

Clinical Trials on Short-Chain Fructooligosaccharide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe