Pouchitis
Conditions
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.
Interventions
DRUGShort-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally for 12 months
DRUGMaltodextrin
4 chews (maltodextrin) daily for 12 months
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year | 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). |
Countries
United States
Outcome results
None listed