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NCT05852587 · ClinicalTrials.gov registry record · Phase 1
Xylitol Use for Decolonization of C. Difficile in Patients With IBD
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT05852587: Clinical Trial Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT05852587 is a Phase 1 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05852587, a Phase 1 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Absence of C. difficile via PCR in week 8 stool sample
Interventions
- DRUG Placebo
- DRUG Xylitol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2033-01-01 |
| Phase | Phase 1 |
What is known before NCT05852587 opens enrollment
NCT05852587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05852587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05852587 about?
NCT05852587 is a clinical study titled "Xylitol Use for Decolonization of C. Difficile in Patients With IBD". 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 ar...
What is the current status of trial NCT05852587?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2026-08-01. Estimated completion is 2033-01-01.
What interventions are being tested in trial NCT05852587?
The interventions under investigation include: Placebo (DRUG), Xylitol (DRUG).
Who is sponsoring clinical trial NCT05852587?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05852587's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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