Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients With Inflammatory Bowel Disease
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
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 ≤ 4; 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
Treatment groups
69 Participants
are divided into 2 treatment groupsLocations
1Brigham and Women's Hospital02115, BostonMassachusetts, United States
Sponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
Source ClinicalTrials.gov