Overview

C. Difficile and Ursodiol

Status:
Active, not recruiting
Trial end date:
2021-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Treatments:
Ursodeoxycholic Acid
Criteria
Inclusion Criteria:

- Male and female patients with recurrent C. difficile colitis

- 18 years of age and older

- Capable of giving informed consent

Exclusion Criteria:

- Patients with other gastrointestinal problems prone to cause diarrhea if they cannot
be controlled for the period of the study. Lactose intolerance or gluten enteropathy
are not an exclusion provide that the potential subject is asymptomatic and can be
expected to adhere to the appropriate dietary regimen.

- Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets
or components of the formulations.

- Patients not available for long-term follow-up (2 months) by their physician will be
excluded from the study.