Not Yet RecruitingEarly Phase 1

Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease

United States69 participantsStarted 2026-09-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 ≤ 4; Partial Mayo score ≤ 4)
✓. Presenting for outpatient colonoscopy or clinic appointment

Exclusion criteria

✕. 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.
✕. Currently pregnant or breastfeeding

What they're measuring

Safety and Efficacy of Xylitol

Timeframe: 8 weeks

C. Diff Decolonization

Timeframe: 8 weeks

Trial details

NCT IDNCT06799039

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-09-01

Contact for this trial

Heidy Cabral

617-525-7322 hjcabral@bwh.harvard.edu

View on ClinicalTrials.gov More Inflammatory Bowel Disease (IBD) trials