C. Difficile and Ursodiol

Phase 4

Completed

• Conditions: Diarrhea
• Interventions: Drug: Ursodiol

• Registration Number: NCT02748616
• Lead Sponsor: NYU Langone Health

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 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.

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 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.

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-21
• Study First Posted: 2016-04-22
• Study Start: 2017-03-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-01-31
• Results First Submitted: 2021-01-27
• Results First Submitted QC: 2021-01-27
• Results First Posted: 2021-02-17
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ursodiol	Ursodiol	Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.

Primary Outcome Measures

Name	Time	Method
Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern	2 months

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States