Ursodeoxycholic Acid in C. Difficile Infection

Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05526807

Enrollment

Registered

2022-09-02

Start date

2019-05-08

Completion date

2023-12-31

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridioides Difficile Infection

Brief summary

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

Interventions

DRUGUrsodeoxycholic acid

Oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To assess tolerability to oral ursodeoxycholic acid	6 weeks	Assess for side effects

Secondary

Measure	Time frame	Description
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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026