Xylitol Use for Decolonization of C. Difficile in Patients With IBD

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Inflammatory Bowel Diseases, Clostridioides Difficile Infection

In brief

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.

Key facts

Study ID

NCT05852587

Run by

Brigham and Women's Hospital

People needed

99

Starts

2026-08-01

Expected to finish

2033-01-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Unable to provide consent
• Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)
• Unable to complete study procedures
• Chronic use of antibiotics
• Inability or unwillingness to swallow capsules
• Allergy to xylitol
• Stool positive for Listeria monocytogenes

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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