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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: XylitolExperimental Treatment1 Intervention

Patients in this arm will be receiving 7.5g/day of Xylitol over a 4 week period.

Group II: SucralosePlacebo Group1 Intervention

Patients in this arm will be receiving 250mg/day of sucralose over a 4 week period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Xylitol

2009

Completed Phase 4

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,611 Previous Clinical Trials

11,470,447 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: Sucralose, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers actively seeking participants for this experiment?

"Clinicaltrials.gov reveals that this specific investigation, which was initially posted on September 1st 2023, is not currently recruiting candidates. However, there are 242 other trials actively enrolling patients right now."

Answered by AI