Back to resultsUrsodeoxycholic Acid in C. Difficile Infection
Primary Purpose
Clostridioides Difficile Infection
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ursodeoxycholic acid
Sponsored by
About this trial
This is an interventional prevention trial for Clostridioides Difficile Infection
Eligibility Criteria
Inclusion Criteria:
- Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days
Exclusion Criteria:
• Pregnant or Breast-feeding
- Gall bladder inflammation
- Frequent episodes of biliary colic
- Occlusion of the common bile duct or cystic duct
- Active small intestinal inflammation
- Previous resection of distal small intestine
- Treatment with bile salt binding agents, ciclosporin or ciprofloxacin
- Diarrhoea (from any cause) at study initiation
- hypersensitivity to bile acids or any excipient of the formulation
- Life expectancy less than 6 months
Sites / Locations
- Nottingham University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ursodeoxycholic acid
Arm Description
Only one arm - subjects receiving ursodeoxycholic acid
Outcomes
Primary Outcome Measures
To assess tolerability to oral ursodeoxycholic acid
Assess for side effects
Secondary Outcome Measures
To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid
Recurrence of C. difficile infection to be confirmed by stool test for toxin(s)
Full Information
NCT ID
NCT05526807
First Posted
August 31, 2022
Last Updated
September 6, 2022
Sponsor
Nottingham University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT05526807
Brief Title
Ursodeoxycholic Acid in C. Difficile Infection
Official Title
Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ursodeoxycholic acid
Arm Type
Experimental
Arm Description
Only one arm - subjects receiving ursodeoxycholic acid
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Intervention Description
Oral
Primary Outcome Measure Information:
Title
To assess tolerability to oral ursodeoxycholic acid
Description
Assess for side effects
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid
Description
Recurrence of C. difficile infection to be confirmed by stool test for toxin(s)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days
Exclusion Criteria:
• Pregnant or Breast-feeding
Gall bladder inflammation
Frequent episodes of biliary colic
Occlusion of the common bile duct or cystic duct
Active small intestinal inflammation
Previous resection of distal small intestine
Treatment with bile salt binding agents, ciclosporin or ciprofloxacin
Diarrhoea (from any cause) at study initiation
hypersensitivity to bile acids or any excipient of the formulation
Life expectancy less than 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yashwant Mahida
Phone
441159249924
Email
yash.mahida@nottingham.ac.uk
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yashwant Mahida
Phone
+441159249924
Email
yash.mahida@nottingham.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Ursodeoxycholic Acid in C. Difficile Infection
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