drugset / Trial / NCT02748616

C. Difficile and Ursodiol

NCT02748616

Phase 4 Completed 9 enrolled NYU Langone Health
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-03-01
Primary completion
2019-11-01
Completion
2020-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 300 mg

Indications