Brigham and Women's Hospital
Jessica Ravikoff Allegretti
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.
Inflammatory Bowel Disease (IBD)
Clostridioides Difficile Infection
Xylitol
EARLY_PHASE1
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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 180 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients with Inflammatory Bowel Disease |
| Actual Study Start Date : | 2025-09-01 |
| Estimated Primary Completion Date : | 2030-09-01 |
| Estimated Study Completion Date : | 2031-09-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115