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Xylitol Use for Decolonization of C. Difficile in Patients With IBD
Sponsor: Brigham and Women's Hospital
Summary
This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. All arms will receive an identical capsule dosing for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.
Official title: Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2026-08-01
Completion Date
2033-01-01
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
Xylitol
Xylitol is a sugar alcohol and considered a GRAS substance by the FDA. Xylitol is also an FDA approved as a food additive. Xylitol will be used as a treatment for the decolonization of C. difficile and will be given in gel capsules. The xylitol provided will be prepared by the BWH investigational drug service and ordered from MEDISCA suppliers. It will be 100% pure. Xylitol has a distinct taste and therefore it will be administered in gel capsules as opposed to an oral solution to maintain blinding.
Placebo
The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States