Status:
COMPLETED
C. Difficile and Ursodiol
Lead Sponsor:
NYU Langone Health
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ur...
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...
Eligibility Criteria
Inclusion
- Male and female patients with recurrent C. difficile colitis
- 18 years of age and older
- Capable of giving informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02748616
Start Date
March 1 2017
End Date
January 31 2020
Last Update
January 11 2022
Active Locations (1)
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1
New York University Langone Medical Center
New York, New York, United States, 10016