CompletedPhase 4

C. Difficile and Ursodiol

United States9 participantsStarted 2017-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern

Timeframe: 2 months

Trial details

NCT IDNCT02748616

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-01

Results submitted2021-01-27

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