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Xylitol for Inflammatory Bowel Disease

Phase 1
Waitlist Available
Led By Jessica R Allegretti, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial will assess safety & effectiveness of xylitol to treat C. difficile in IBD patients. 72 patients will be randomized and take capsules twice daily for 4 wks, with tests at baseline & 4, 8, 26 & 52 weeks.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if xylitol can help remove C. difficile bacteria in IBD patients compared to a placebo (sucralose). Patients are randomly chosen to get either xylitol or sucralose in capsule form twice daily for four weeks, with follow-up testing up to one year.See study design
What are the potential side effects?
Potential side effects of xylitol may include digestive discomfort such as bloating, gas, and diarrhea. Sucralose is generally recognized as safe but could also cause similar digestive issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C.difficile decolonization
safety and tolerability
Secondary outcome measures
C. difficile infection
IBD clinical outcomes
biomass of C.difficile

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose B of XylitolExperimental Treatment1 Intervention
Patients in this are will be receiving 15g/day of Xylitol over a 4 week period.
Group II: Dose A of XylitolExperimental Treatment1 Intervention
Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.
Group III: PlaceboPlacebo Group1 Intervention
Patients in this arm will be receiving placebo over a 4 week period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xylitol
2009
Completed Phase 4
~410

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,622 Previous Clinical Trials
11,468,658 Total Patients Enrolled
Jessica R Allegretti, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Sucralose (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05852587 — Phase 1
Clostridioides difficile Infection Research Study Groups: Placebo, Dose B of Xylitol, Dose A of Xylitol
Clostridioides difficile Infection Clinical Trial 2023: Sucralose Highlights & Side Effects. Trial Name: NCT05852587 — Phase 1
Sucralose (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852587 — Phase 1
~66 spots leftby Jan 2032
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