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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
13
4 chews (8.0 g scFOS) orally for 12 months
4 chews (maltodextrin) daily for 12 months
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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
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