Ursodeoxycholic Acid in C. Difficile Infection

N/ATerminatedNCT05526807

Nottingham University Hospitals NHS Trust6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Clostridioides Difficile Infection

Interventions

Ursodeoxycholic acidDRUG

Oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Outcomes

Primary Outcomes

To assess tolerability to oral ursodeoxycholic acid

Assess for side effects

Time frame: 6 weeks

Secondary Outcomes

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)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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