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NCT06884748 · ClinicalTrials.gov registry record · Early Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
A Early Phase 1 study, sponsored by Medical College of Wisconsin.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT06884748: Clinical Trial Early Phase 1 study, sponsored by Medical College of Wisconsin.
NCT06884748 is a Early Phase 1 study that has not yet begun recruiting, run by Medical College of Wisconsin. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06884748, a Early Phase 1 study, has not yet begun recruiting, sponsored by Medical College of Wisconsin.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to determine whether Ursodeoxycholic Acid (UDCA) can help prevent recurrence of Clostridioides difficile (C. diff) colitis when used along with standard antibiotic treatment. C. diff colitis is a serious infection that can return after treatment, and researchers want to see if UDCA can reduce this risk. This study aims to answer three main questions. First, can UDCA help prevent C. diff from returning after standard treatment? Second, does adding UDCA to treatment lower the need for repeated antibiotic use? Third, is UDCA safe and well-tolerated for people with C. diff? Participants in the study will be adults diagnosed with C. diff colitis who have risk factors for recurrence. Each participant will receive standard antibiotic treatment, which may include Vancomycin, Fidaxomicin, or Metronidazole. In addition to their antibiotic therapy, participants will take UDCA at a dose of 500 mg three times a day for up to eight weeks. If a participant's stool test shows they are C. diff negative at four weeks, they will stop taking UDCA early. Researchers will monitor participants throughout the study. Stool samples will be tested at the beginning, after four weeks, and at the end of the study. If a participant develops diarrhea, a stool test will check for C. diff. If C. diff is negative, the UDCA dose will be reduced. Weekly phone calls will be made to check for side effects and ensure participants are following the treatment plan. C. diff colitis is a common and serious infection, with up to 46 percent of high-risk patients experiencing recurrence. Current treatments rely on antibiotics, which can disrupt gut bacteria and increase the risk of reinfection. UDCA is a naturally occurring bile acid that may help prevent C. diff from growing, reducing the need for repeated antibiotic treatment. If successful, this study could introduce a new way to prevent C. diff from coming back, helping patients recover more effectively while reducing a
Primary Outcome
Absence of recurrent C. difficile recurrence based on symptoms and standard of care testing at 3 months and repeat stool testing at 8 weeks.
Interventions
- DRUG Ursodiol 500 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-05-01 |
| Est. Completion | 2028-05-01 |
| Phase | Early Phase 1 |
What is known before NCT06884748 opens enrollment
NCT06884748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Ursodiol 500 MG is the first listed.
NCT06884748 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06884748 about?
NCT06884748 is a clinical study titled "Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy". The goal of this clinical trial is to determine whether Ursodeoxycholic Acid (UDCA) can help prevent recurrence of Clostridioides difficile (C. diff) colitis when used along with standard antibiotic treatment. C. diff colitis is a serious infection that can return after treatment, and researchers wa...
What is the current status of trial NCT06884748?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2026-05-01. Estimated completion is 2028-05-01.
What interventions are being tested in trial NCT06884748?
The interventions under investigation include: Ursodiol 500 MG (DRUG).
Who is sponsoring clinical trial NCT06884748?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06884748's enrollment target sits among peer trials
30 807th of 2000 higher than 1,074 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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