NCT02748616

C. Difficile and Ursodiol

A Clinical Trial for the Off Label Use of Ursodiol for the Prevention of Recurrent C. Difficile Colitis and Diarrhea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The non-investigational reference therapies, Metronidazole, Vancomycin and fidaxomicin , are FDA-approved antibiotics currently in use today because of their effectiveness in suppressing the growth of C. difficile and therefore quickly eliminating the colitis and diarrhea. However, they do not promote the restoration of the normal bacterial flora. Therefore, when medication is stopped, the C. difficile colitis returns. In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence.

Conditions

• Diarrhea

Interventions

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

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-11-01
• Completion: 2020-01-31
• First posted: 2016-04-22
• Last updated: 2022-01-11
• Results posted: 2021-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study