Xylitol Use for Decolonization of C. Difficile in Patients With IBD
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent.
Male or female ≥ 18 years of age
IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)
Disqualifiers
Unable to provide consent
Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)
Unable to complete study procedures
Chronic use of antibiotics
Trial design
Treatments tested in this trial
- Xylitol
- Placebo
Treatment groups
99 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov