Clinical trial

Xylitol Use for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

Name

2023P001327

Description

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.

Trial arms

Trial start

2025-01-01

Estimated PCD

2032-01-01

Trial end

2033-01-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Xylitol

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.

Arms:

Dose A of Xylitol, Dose B of Xylitol

Placebo

The placebo will be administered by the BWH investigational drug services. The placebo will be composed of cellulose microcrystal.

Arms:

Placebo

Size

Primary endpoint

C.difficile decolonization

8 weeks

safety and tolerability

8 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 99, 'type': 'ESTIMATED'}}

Updated at

2024-05-13

1 organization

1 product

1 drug

2 indications

Organization

Brigham and Women's Hospital

Product

Xylitol

Indication

Inflammatory Bowel Disease

Indication

Clostridioides difficile infection

Drug

Varlilumab