Xylitol Use for Decolonization of C. Difficile in Patients With IBD
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brigham and Women's Hospital
- Trial code
- NCT05852587
- Record updated
- 25 February 2026
- Original description
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.Read full original descriptionShow less
Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
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.
Inclusion: Signed informed consent; Male or female ≥ 18 years of age; IBD diagnosis (CD, UC or indeterminant Colitis will be permitted); Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4); Presenting for outpatient colonoscopy or clinic appointment for any indication.
Exclusion: Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy); Allergy to xylitol; Unable to provide consent; Unable to complete study procedures; Chronic use of antibiotics; Inability or unwillingness to swallow capsules; Stool positive for Listeria monocytogenes.