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

Inflammatory Bowel Diseases Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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 a dose of 10 capsules BID for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.

Clinical Trial Description

This randomized, placebo-controlled, dose-ranging 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 or clinic appointment for any reason at Brigham and Women's Hospital will be eligible for enrollment. Participants will be screened during colonoscopy for C. difficile colonization via colonic wash sampling. Participants who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo. The treatment arm will receive either BID dosing of 7.5 or 15 grams via gel capsule for 4 weeks. The placebo arm will also receive BID dosing via gel capsule for 4 weeks. Participants will end dosing at week 4 but monitoring will continue to week 8. Both participants and study team will be blinded to treatment arm allocation. Participants will be assessed through week 8 for the primary outcome, decolonization. Safety and tolerability outcomes will be assessed through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI will be evaluated at week 8 and week 52. Participants will also be followed through week 52 for long-term safety, efficacy, and clinical outcomes. Disease activity and symptoms will be recorded from time of informed consent through to 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. The primary outcome, decolonization of C. Difficile at week 8, will be confirmed via stool sampling. Additional C. difficile testing will be done at week 26 and week 52. The study will prospectively enroll approximately 56 adult participants at a single center. Participants that experience intolerable adverse events will be withdrawn from the study and will be considered treatment failures. Data from these patients will be carried forward from last evaluable assessment. ;

Related Conditions & MeSH terms

• Clostridioides Difficile Infection
• Clostridium Infections
• Inflammatory Bowel Diseases
• Intestinal Diseases

• NCT number: NCT05852587
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Contact: Heidy Cabral
• Phone: 6175257322
• Email: hjcabral@bwh.harvard.edu
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 1, 2025
• Completion date: January 1, 2033