Xylitol Use for Decolonization of C. Difficile in Patients With IBD

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05852587
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Clostridioides Difficile Infection
  • Inflammatory Bowel Diseases

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. 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 and therefore it will be administered in gel capsules as opposed to an oral solution to maintain blinding.
  • Placebo — DRUG
    The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Feb 2026
Primary completion
Jan 1, 2032
Completion
Jan 1, 2033

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose A of Xylitol
    Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.
  • Experimental: Dose B of Xylitol
    Patients in this are will be receiving 15g/day of Xylitol over a 4 week period.
  • Placebo Comparator: Placebo
    Patients in this arm will be receiving placebo over a 4 week period.

Primary Outcome Measure

C.difficile decolonization [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Jessica Allegretti, MD, MPH
[email protected]
617-732-6389
Heidy Cabral
[email protected]
617-525-7322

Find similar trials in Boston, MA

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

Related Studies