CompletedNCT02203955Updated Feb 24, 2020

Study of Sc-FOS for Pouchitis Prevention

A Phase 1 interventional study of Short-Chain Fructooligosaccharide and Maltodextrin in Pouchitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-24.

Sponsored by Mayo Clinic · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 13
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

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 studied

Pouchitis

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Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 13 participants (actual)

Study arms

Active comparator
Short-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally per day for 12 months
Drug: Short-Chain Fructooligosaccharide
Placebo comparator
Maltodextrin
4 chews (maltodextrin) daily for 12 months
Drug: Maltodextrin

Interventions

DrugShort-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally for 12 months
DrugMaltodextrin
4 chews (maltodextrin) daily for 12 months

What researchers measure

Primary outcomes

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).
Time frame: baseline, 1 year

Study locations

1 site

Mayo Clinic in Rochester
Rochester, Minnesota 55905, United States

References and documents

Registry details

Key details

Study ID: NCT02203955
Lead sponsor: Mayo Clinic
Responsible party: Laura E. Raffals, M.D (Assistant Professor of Medicine, Mayo Clinic) — Principal investigator
First posted: Jul 30, 2014
Start date: Aug 2014
Primary completion: Dec 2017
Completion: Dec 2018
Last update: Feb 24, 2020

Study contacts

Laura Raffals, MD

principal investigator · Mayo Clinic

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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