CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9 enrolled
Drug / intervention
Ursodioldrug
Likely dose
Ursodiol 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02748616
NCT02748616Phase 4Completed
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A Clinical Trial for the Off Label Use of Ursodiol for the Prevention of Recurrent C. Difficile Colitis and Diarrhea

NYU Langone Health·interventional·Posted Apr 22, 2016·Updated Jan 11, 2022

In Brief

A Phase 4 clinical trial evaluating Ursodiol for Diarrhea. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 22, 2016
Enrollment StartMar 1, 2017
Primary CompletionNov 1, 2019
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.2 years ago

Interventions

Ursodioldrug

Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.