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.