C. Difficile and Ursodiol
C. Difficile and Ursodiol
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.
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.
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.