Study of Sc-FOS for Pouchitis Prevention
Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
July 30, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 24, 2020
February 1, 2020
3.3 years
July 16, 2014
February 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change in Pouchitis Disease Activity Index (PDAI) at One 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
Study Arms (2)
Short-Chain Fructooligosaccharide
ACTIVE COMPARATOR4 chews (8.0 g scFOS) orally per day for 12 months
Maltodextrin
PLACEBO COMPARATOR4 chews (maltodextrin) daily for 12 months
Interventions
4 chews (8.0 g scFOS) orally for 12 months
Eligibility Criteria
You may qualify if:
- Age 18-65 years.
- History of ulcerative colitis
- Ileostomy closure after IPAA
- Ability to give appropriate consent
You may not qualify if:
- Crohn's disease.
- Perianal disease (including abscess, fissure, or stricture)
- Pregnancy
- Lactation
- Concurrent treatment for IBD or pouchitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Raffals, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
July 16, 2014
First Posted
July 30, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
February 24, 2020
Record last verified: 2020-02