A Clinical Trial for the Off Label Use of Ursodiol for the Prevention of Recurrent C. Difficile Colitis and Diarrhea
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ursodiol
Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.
Intervention: Ursodiol (Drug)
Outcomes
Primary Outcomes
Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern
Time Frame: 2 months
Secondary Outcomes
No secondary outcomes reported