Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
Early 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 Disease (IBD) and Clostridioides Difficile Infection.
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
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 69 participants are expected to take part.
- Start date: 2026-09-01 (planned).
- Main results expected around 2030-09-01 (estimate from the record).
- 1 study site listed in United States.
Main thing being measured
- Safety and Efficacy of Xylitol (8 weeks)
In the researchers’ words
This 3+3 dose escalation pilot trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the Inflammatory Bowel Disease (IBD) patient population.
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 | Early Phase 1 |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Clostridioides Difficile Infection |
| Lead sponsor | Brigham and Women's Hospital |
| Enrollment | 69 (estimated) |
| Start date | 2026-09-01 |
| Primary completion (est.) | 2030-09-01 |
| First posted | 2025-01-29 |
| Last updated | 2025-12-16 |
| Official title | Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06799039 |
Interventions
- Xylitol (Drug)
Xylitol is a sugar alcohol and considered a GRAS substance by the FDA. Patients will be consecutively enrolled into one of five dosing including 1g, 2g, 5g, 7g and 9g.
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 ≤ 4; Partial Mayo score ≤ 4) 5. Presenting for outpatient colonoscopy or clinic appointment 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. Currently pregnant or breastfeeding
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.