Xylitol Use for Decolonization of C. Difficile in Patients With IBD
Phase 1 · Testing Xylitol · 1 site · Brigham and Women's Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Xylitol (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases and Clostridioides Difficile Infection.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Signed informed consent.
- Male or female ≥ 18 years of age
- IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
Plus 2 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 99 participants are expected to take part.
- Start date: 2026-08-01 (planned).
- Main results expected around 2032-01-01 (estimate from the record).
- 1 study site listed in United States.
Main thing being measured
- C.difficile decolonization (8 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Clostridioides Difficile Infection |
| Lead sponsor | Brigham and Women's Hospital |
| Enrollment | 99 (estimated) |
| Start date | 2026-08-01 |
| Primary completion (est.) | 2032-01-01 |
| First posted | 2023-05-10 |
| Last updated | 2026-02-25 |
| Official title | Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT05852587 |
Interventions
- Xylitol (Drug)
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 an… - Placebo (Drug)
The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.
Full eligibility criteria (from the record)
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. Stool positive for Listeria monocytogenes
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital | Boston, Massachusetts | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.