Xylitol for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those with chronic use of antibiotics, which might suggest some restrictions on certain medications.
How is the treatment with Xylitol and Sucralose different from other treatments for inflammatory bowel disease?
This treatment is unique because it involves dietary components, Xylitol and Sucralose, which are not standard drugs for inflammatory bowel disease. Traditional treatments often include medications like salicylates and steroids, while this approach focuses on dietary support, which is an emerging area of research for managing conditions like Crohn's disease and ulcerative colitis.12345
What data supports the effectiveness of the treatment Xylitol for Inflammatory Bowel Disease?
There is no direct evidence from the provided research articles that supports the effectiveness of Xylitol specifically for treating Inflammatory Bowel Disease. However, dietary interventions, in general, have been shown to have some benefits in managing symptoms of IBD, and further studies are needed to explore the potential role of specific dietary components like Xylitol.46789
Who Is on the Research Team?
Jessica Allegretti, MD, MPH
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Inflammatory Bowel Disease (IBD), including Crohn's disease, ulcerative colitis, or indeterminate colitis. Participants must be scheduled for an outpatient colonoscopy and willing to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either placebo or one of two doses of xylitol for 4 weeks
Follow-up
Participants are monitored for safety, efficacy, and disease activity through week 52
What Are the Treatments Tested in This Trial?
Interventions
- Sucralose
- Xylitol
Sucralose is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor