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

• Status: Not yet recruiting
• Trial end date: 2029-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized placebo controlled study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 72 patients who meet eligibility criteria will be randomized 1:1 to either the xylitol or sucralose (placebo) arm. Both arms will receive a dose comprising five capsules BID for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital

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. Presenting for outpatient colonoscopy 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 or sucralose