C. Difficile and Ursodiol

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NYU Langone Health

Status and phase

Completed
Phase 4

Conditions

Diarrhea

Treatments

Drug: Ursodiol

Study type

Interventional

Funder types

Other

Identifiers

NCT02748616
15-01348

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Ursodiol
Experimental group
Description:
Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.
Treatment:
Drug: Ursodiol

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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