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NCT05526807 Clinical Trial

Ursodeoxycholic Acid in C. Difficile Infection

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

Clinical Trial Details — Status: Terminated

Administrative data
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

Study information
Verified date April 2024
Source Nottingham University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ursodeoxycholic acid
Oral

Locations
Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
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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