Back to resultsC. Difficile and Ursodiol
Primary Purpose
Diarrhea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ursodiol
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Colitis, Bile
Eligibility 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.
Sites / Locations
- New York University Langone Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ursodiol
Arm Description
Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.
Outcomes
Primary Outcome Measures
Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02748616
Brief Title
C. Difficile and Ursodiol
Official Title
A Clinical Trial for the Off Label Use of Ursodiol for the Prevention of Recurrent C. Difficile Colitis and Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Colitis, Bile
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ursodiol
Arm Type
Experimental
Arm Description
Subjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.
Intervention Type
Drug
Intervention Name(s)
Ursodiol
Other Intervention Name(s)
Urso
Intervention Description
Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.
Primary Outcome Measure Information:
Title
Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman Javitt, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
C. Difficile and Ursodiol
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