Xylitol Use for Decolonization of C. Difficile in Patients With IBD

Launched by BRIGHAM AND WOMEN'S HOSPITAL · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Xylitol Use for Decolonization of C. Difficile in Patients With IBD," is exploring whether xylitol, a natural sugar substitute, can help remove the bacteria Clostridioides difficile (C. difficile) in patients with Inflammatory Bowel Diseases (IBD) such as Crohn's disease and ulcerative colitis. The study will involve 99 participants who will be divided into three groups: two groups will receive different doses of xylitol, and one group will receive a placebo (a harmless pill without active ingredients). Each participant will take their assigned capsules for four weeks, and the researchers will check how their gut bacteria and C. difficile levels change at several points during the study.

To join the trial, participants must be at least 18 years old and have a diagnosis of IBD that is currently inactive or only mildly active. They should also be able to provide consent and be scheduled for an outpatient colonoscopy or appointment. However, individuals with certain conditions, such as previous significant bowel surgery or chronic antibiotic use, will not be eligible. Throughout the study, participants can expect regular check-ins and testing to monitor their health and the effects of the treatment. This trial is not yet recruiting participants, but it aims to gather important information on the safety and effectiveness of xylitol for this purpose.

Gender

ALL

Eligibility criteria

• 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 ≤ 7; Partial Mayo score ≤ 4)
• • 5. Presenting for outpatient colonoscopy or clinic appointment for any indication
• 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. Stool positive for Listeria monocytogenes