Ursodeoxycholic Acid in C. Difficile Infection
Not Applicable
Terminated
- Conditions
- Clostridioides Difficile Infection
- Interventions
- Registration Number
- NCT05526807
- Lead Sponsor
- Nottingham University Hospitals NHS Trust
- Brief Summary
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ursodeoxycholic acid Ursodeoxycholic acid Only one arm - subjects receiving ursodeoxycholic acid
- Primary Outcome Measures
Name Time Method To assess tolerability to oral ursodeoxycholic acid 6 weeks Assess for side effects
- Secondary Outcome Measures
Name Time Method To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid 12 weeks Recurrence of C. difficile infection to be confirmed by stool test for toxin(s)
Trial Locations
- Locations (1)
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom