This randomized controlled 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 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 may have inactive or active IBD at the time of the colonoscopy to be eligible.~Participants who meet eligibility criteria will be randomized 1:1 to either sucralose (control) or xylitol. Both arms will receive BID dosing of 7.5 grams via gel capsule for 4 weeks. Participants will end dosing at week 4 but monitoring will continue through to Week 8. Both participants and study team will be blinded to treatment arm allocation.~Participants will be assessed thorough 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 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.~The primary outcome, the decolonization of C. difficile at Week 8 will be confirmed via stool sampling. Additional C. difficile testing will be done at Week 26 and 52.~Participants that experience intolerable adverse events will be withdrawn from the study and replaced.~The study will prospectively enroll approximately 72 adult participants at a single center
This is a randomized placebo controlled study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 72 patients who meet eligibility criteria will be randomized 1:1 to either the xylitol or sucralose (placebo) arm. Both arms will receive a dose comprising five capsules BID for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.