NCT05852587Not yet recruitingPhase 1
Xylitol Use for Decolonization of C. Difficile in Patients With IBD
Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 2 May 2023
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Jan 2032
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05852587
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 99
- From 1 Aug 2026 to the primary completion date, 1 Jan 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)
Other illness
- Allergy to xylitol
Other
- Unable to provide consent
- Unable to complete study procedures
- Chronic use of antibiotics
- Inability or unwillingness to swallow capsules
- Stool positive for Listeria monocytogenes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.