Clostridioides Difficile Infection Clinical Trial
Official title:
Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection
NCT number | NCT05526807 |
Other study ID # | 17GA025 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2019 |
Est. completion date | December 31, 2023 |
Verified date | April 2024 |
Source | Nottingham University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid
Status | Terminated |
Enrollment | 6 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Nottingham University Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess tolerability to oral ursodeoxycholic acid | Assess for side effects | 6 weeks | |
Secondary | 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) | 12 weeks |
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