C. Difficile and Ursodiol
A Clinical Trial for the Off Label Use of Ursodiol for the Prevention of Recurrent C. Difficile Colitis and Diarrhea
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedResults Posted
Study results publicly available
February 17, 2021
CompletedJanuary 11, 2022
December 1, 2021
2.7 years
April 20, 2016
January 27, 2021
December 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern
2 months
Study Arms (1)
Ursodiol
EXPERIMENTALSubjects will begin to take 300 mg Ursodiol following Visit #1 and continue for a total of 8 (eight) weeks.
Interventions
Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.
Eligibility Criteria
You may qualify if:
- Male and female patients with recurrent C. difficile colitis
- years of age and older
- Capable of giving informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University Langone Medical Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Norman Javitt, MD
- Organization
- NYU Langone Health
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Javitt, MD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2016
First Posted
April 22, 2016
Study Start
March 1, 2017
Primary Completion
November 1, 2019
Study Completion
January 31, 2020
Last Updated
January 11, 2022
Results First Posted
February 17, 2021
Record last verified: 2021-12