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

NCT ID: NCT06799039

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-01
• Study Completion Date: 2031-09-01

Brief 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.

Detailed Description

Participants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Women's Hospital or clinic appointment at the Crohn's and Colitis Center will be eligible for enrollment. Participants will be screened for C. difficile colonization via colonic wash sampling during colonoscopy or whole stool at or following clinic appointment. Participants may only have inactive or mild IBD at the time of the colonoscopy or clinic visit to be eligible.

Participants who meet eligibility criteria will be enrolled into one of five consecutively increasing dosing groups of xylitol. The dose A treatment arm will receive a daily dose of 1 gram of xylitol for 7 days. The dose B treatment arm will receive a daily dose of 2 grams of xylitol for 7 days. The dose C treatment group will receive a daily dose of 5 grams of xylitol for 7 days. The dose D treatment group will receive a daily dose of 7 grams of xylitol for 7 days. The dose E treatment group will receive a daily dose of 9 grams of xylitol for 7 days. Participants will end dosing at day 7 but monitoring will continue through to week 8.

Participants who meet eligibility criteria but do not want to participate in the trial will also be eligible to enroll in an observational cohort. Participants in the observational cohort will be assessed at Week 1, 4 and 8, following confirmation of colonization. Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring.

Participants in the treatment cohort will be assessed thorough week 8 for the primary outcome, determining the maximum tolerated dosage of xylitol. C. difficile decolonization will be assessed through week 8. Participants will also receive weekly phone call for assessment of symptoms and tolerability through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI will be evaluated at week 8, and week 26. Participants will also be followed through week 26 for long-term safety, efficacy, and clinical outcomes. Disease activity and symptoms will be recorded from informed consent through the week 26 trial visit.

The primary outcome, determining the maximum tolerated dose of xylitol at week 8 will be confirmed via adverse event reporting. Additional C. difficile testing will be done at week 26.

The study will prospectively enroll between 15 and 30 adult participants at a single center. Participants that experience intolerable adverse events will be withdrawn from the study and will be considered treatment failures.

Conditions

Inflammatory Bowel Disease (IBD); Clostridioides Difficile Infection

Keywords

C. Difficile; Decolonization; IBD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Finding Cohort

One of five consecutively increasing dosing groups of xylitol

Group Type: EXPERIMENTAL

Xylitol

Intervention Type: 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.

Observational Cohort

Participants will be assessed for rates of spontaneous decolonization, stool sample testing and IBD scoring.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Xylitol

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.

Intervention Type: DRUG

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 ≤ 4; Partial Mayo score ≤ 4)

5. Presenting for outpatient colonoscopy or clinic appointment

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. Currently pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jessica Ravikoff Allegretti

Jessica R. Allegretti, MD, MPH, FACG, AGAF, Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Allegretti, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Heidy Cabral

Role: CONTACT

Phone: 617-525-7322

Email: hjcabral@bwh.harvard.edu

Jessica Allegretti, MD MPH

Role: CONTACT

Phone: 617-732-6389

Facility Contacts

Heidy Cabral

Role: primary

Other Identifiers

2025P000210

Identifier Type: -

Identifier Source: org_study_id