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NCT02748616 · ClinicalTrials.gov registry record · Phase 4
C. Difficile and Ursodiol
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT02748616 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 9 participants.
The verdict
NCT02748616, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid composition (80% deoxycholic acid) to maintain growth suppression.
Interventions
- DRUG Ursodiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2020-01-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02748616
The ClinicalTrials.gov registry entry for NCT02748616 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ursodiol is the first listed.
NCT02748616 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02748616 about?
NCT02748616 is a clinical study titled "C. Difficile and Ursodiol". In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), an...
What is the current status of trial NCT02748616?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2017-03-01. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT02748616?
The interventions under investigation include: Ursodiol (DRUG).
Who is sponsoring clinical trial NCT02748616?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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