Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
Brigham and Women's Hospital
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.
Description
Participants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Women's Hospital will be eligible for enrollment. Participants will be screened for C. difficile colonization via colonic wash sampling during colonoscopy. Participants may only have inactive or mild IBD at the time of the colonoscopy to be eligible. Eligible participants will be initially enrolled in the observational cohort until there are 39 subjects enrolled. Participants in the observational cohort will be assessed at Week 1, 4 and 8, following confirmation of colonizat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. 7. Currently preg…
Interventions
- DrugXylitol
Xylitol is a sugar alcohol and considered a GRAS substance by the FDA. Patients will be consecutively enrolled into one of five dosing including 1g, 2g, 5g, 7g and 9g.
Location
- Brigham and Women's HospitalBoston, Massachusetts