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

NCT05852587 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2023P001327
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Clostridioides Difficile Infection

Keywords

Crohn's Disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (2)

• C.difficile decolonization

  Absence of C. difficile via PCR in week 8 stool sample

  8 weeks

• safety and tolerability

  Subject incidence of treatment-emergent adverse events (including treatment-emergent adverse events for clinically significant changes in laboratory parameters and vital signs)

  8 weeks

Secondary Outcomes (4)

• biomass of C.difficile

  8 weeks

• IBD clinical outcomes

  8 weeks

• IBD clinical outcomes

  52 weeks

• C. difficile infection

  52 weeks

Study Arms (3)

Dose A of Xylitol

EXPERIMENTAL

Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.

Drug: Xylitol

Dose B of Xylitol

EXPERIMENTAL

Patients in this are will be receiving 15g/day of Xylitol over a 4 week period.

Drug: Xylitol

Placebo

PLACEBO COMPARATOR

Patients in this arm will be receiving placebo over a 4 week period.

Drug: Placebo

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.

Dose A of Xylitol; Dose B of Xylitol

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 7; Partial Mayo score ≤ 4)
• Presenting for outpatient colonoscopy or clinic appointment for any indication

You may not qualify if:

• 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
• Stool positive for Listeria monocytogenes

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Clostridium Infections; Crohn Disease; Colitis, Ulcerative

Interventions

Xylitol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Jessica R Allegretti, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidy Cabral

CONTACT

6175257322; hjcabral@bwh.harvard.edu

Jessica Allegretti, MD

CONTACT

6177326389; jallegretti@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Crohn's and Colitis Center

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2033
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)