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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06799039
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Clostridioides Difficile Infection
  • Inflammatory Bowel Disease (IBD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
Dec 2025
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
69 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Finding Cohort
    One of five consecutively increasing dosing groups of xylitol
  • No Intervention: Observational Cohort
    Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring.

Primary Outcome Measure

Safety and Efficacy of Xylitol [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Heidy Cabral
[email protected]
617-525-7322

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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