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

Phase 1
Not yet recruiting
Conditions
Inflammatory Bowel Diseases
Clostridioides Difficile Infection
Interventions
Drug: Placebo
Registration Number
NCT05852587
Lead Sponsor
Brigham and Women's Hospital
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.

Detailed Description

This randomized placebo-controlled dose-finding trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the IBD patient population.

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 screening. Participants will be screened for C. difficile colonization via colonic wash sampling during colonoscopy or whole stool following a clinic appointment.

Participants may only have inactive or mild IBD based in clinical scores (see inclusion criteria) to be eligible for screening. Risk factors for colonization will be assessed by comparing colonized vs. not colonized patients.

Participants who are found to be colonized will be randomized 1:1:1 to either placebo or one of two dosing groups of xylitol. The dose A treatment arm will receive 7.5 grams daily of xylitol via gel capsule for 4 weeks. The dose B treatment arm will receive 15 grams daily of xylitol via gel capsule for 4 weeks. The placebo arm will receive identical capsule dosing for 4 weeks. Participants will end dosing at week 4, but monitoring will continue through week 52. Both participants and study team will be blinded to treatment arm allocation.

The primary endpoints assessed are decolonization at week 8 as well as safety and tolerability through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI, which will be evaluated at week 8, week 26 and week 52. Disease activity and symptoms will be recorded from informed consent through the week 52 trial visit.

Stool samples for biomarker assessments and C. difficile testing will be collected at scheduled trial visits per Schedule of Assessments.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
99
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPatients in this arm will be receiving placebo over a 4 week period.
Dose A of XylitolXylitolPatients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.
Dose B of XylitolXylitolPatients in this are will be receiving 15g/day of Xylitol over a 4 week period.
Primary Outcome Measures
NameTimeMethod
C.difficile decolonization8 weeks

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

safety and tolerability8 weeks

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

Secondary Outcome Measures
NameTimeMethod
biomass of C.difficile8 weeks

Change in biomass of C. difficile

C. difficile infection52 weeks

Incidence of patients developing CDI

IBD clinical outcomes52 weeks

Clinical Remission: Partial Mayo score less than 1 \& HBI score less than 5 Clinical Response: A decrease from baseline in the HBI score or SCCAI score by three points

Trial Locations

Locations (1)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

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