Pilot Trial of Xylitol for C. Difficile De-Colonization in Patients with Inflammatory Bowel Disease

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a substance called xylitol, which is a type of sugar alcohol, to see if it can help patients with Inflammatory Bowel Disease (IBD) who also have a Clostridioides difficile infection, often referred to as C. difficile. The research aims to find out if taking xylitol by mouth can safely help clear this infection in patients with inactive or mild forms of IBD. The trial is still in the early stages and has not started recruiting participants yet.

To be eligible for the study, participants must be at least 18 years old, have a diagnosis of IBD (which includes conditions like Crohn's disease or ulcerative colitis), and have mild or inactive symptoms. They should also be preparing for an outpatient colonoscopy or a clinic visit. However, individuals with certain medical histories, such as previous colon surgery or chronic use of antibiotics, would not be able to participate. If someone joins the trial, they can expect to take xylitol capsules and help researchers understand its effects on C. difficile in people with IBD.

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 ≤ 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.