Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
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.
Description
This randomized placebo-controlled dose-finding trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the IBD patient population. Participants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Women's Hospital or clinic appointment at the Crohn's and Colitis Center will be eligible for screening. Participants will be screened for C. difficile colonization via colonic wash sampling during colonoscopy or whole stool following a clinic appointment. Participants may only have inac…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent. 2. Male or female ≥ 18 years of age 3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted) 4. Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4) 5. Presenting for outpatient colonoscopy or clinic appointment for any indication Exclusion Criteria: 1. Unable to provide consent 2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy) 3. Unable to complete study procedures 4. Chronic use of antibiotics 5. Inability or unwillingness to swallow capsules 6. Allergy to xylitol 7.…
Interventions
- DrugXylitol
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.
- DrugPlacebo
The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.
Location
- Brigham and Women's HospitalBoston, Massachusetts