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
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.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
This study's enrollment of 13 is below the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Exclusion Criteria:
4 chews (8.0 g scFOS) orally per day for 12 months
Drug: Short-Chain Fructooligosaccharide
4 chews (maltodextrin) daily for 12 months
Drug: Maltodextrin
4 chews (8.0 g scFOS) orally for 12 months
4 chews (maltodextrin) daily for 12 months
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
Ran from Aug 2014 to primary completion in Dec 2017, 40 months.
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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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