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

Early Phase 1

Not yet recruiting

• Conditions: Inflammatory Bowel Disease (IBD); Clostridioides Difficile Infection
• Interventions: Drug: Xylitol

• Registration Number: NCT06799039
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Study Start: 2025-09-01
• Primary Completion: 2030-09-01
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Finding Cohort	Xylitol	One of five consecutively increasing dosing groups of xylitol

Primary Outcome Measures

Name	Time	Method
Safety and Efficacy of Xylitol	8 weeks	Incidence of Treatment Emergent Adverse Events (TEAEs) through Week 8
C. Diff Decolonization	8 weeks	Proportion of patients decolonized of C. difficile at Week 8

Secondary Outcome Measures

Name	Time	Method
Biomass of C. Difficile	8 weeks	Change in biomass of C. difficile in patients at Week 8
Effect of C. difficile decolonization on Inflammatory Bowel Disease (IBD) clinical outcomes	26 weeks	Change in IBD clinical score at Week 8 and Week 26. IBD clinical scores are used to assess IBD patient symptoms. The assessments are separated between scores for Ulcerative Colitis (UC) and Crohn's Disease (CD). The Harvey Bradshaw Index (HBI) is a clinical assessment for IBD patients with Crohn's disease while Partial Mayo Score is a clinical assessment for Ulcerative Colitis. The scores will be collected at study visit in form of a survey. The HBI score can vary but a score above 8 or 9 is considered severe disease activity. The Partial Mayo Score can range from 0 to 9 and a score above 7 is considered severe disease activity. A decrease in score from baseline to follow-up timepoints is indicative of improved IBD patient symptoms.
C. Difficile infection surveillance	26 weeks	Incidence of patients developing C. Difficile Infection through Week 26

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States