Feasibility Studies to Investigate the Role of Ursodeoxycholic acid in the prevention of Recurrence of C.difficile Infection

Feasibility Studies to Investigate the Role of Ursodeoxycholic acid in the prevention of Recurrence of C.difficile Infection - Ursodeoxycholic acid in C. difficile infection

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001906-27-GB

Enrollment

Registered

2018-08-02

Start date

2018-10-01

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Recurrence of Clostridium difficile infection

Interventions

Trade Name: Ursofalk 250mg hard capsules Product Name: Ursofalk 250mg hard capsules Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ursodeoxycholic acid Concentration unit: mg milligram(s) C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age: 18 years or over • Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days • Absence of diarrhoea at study initiation • Subjects (any gender) capable of giving informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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 or ciclosporin • Currently on antibiotic treatment (for any indication) • Diarrhoea (from any cause) at study initiation • Life expectancy less than 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To measure how patients tolerate taking ursodeoxycholic acid for a period of 6 weeks. (We will regularly check their symptoms and compliance with the 6 week course of treatment with ursodeoxycholic acid) ;Secondary Objective: We will look at whether any participants have a recurrence of C.difficile infection and how many of them do so. ;Primary end point(s): The primary endpoint is the successful completion of the 12 week period of study	—

Measure

Time frame

Main Objective: To measure how patients tolerate taking ursodeoxycholic acid for a period of 6 weeks. (We will regularly check their symptoms and compliance with the 6 week course of treatment with ursodeoxycholic acid) ;Secondary Objective: We will look at whether any participants have a recurrence of C.difficile infection and how many of them do so. ;Primary end point(s): The primary endpoint is the successful completion of the 12 week period of study

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Countries

United Kingdom

Contacts

Public ContactProf. Mahida Yashwant

Nottingham University Hospitals NHS Trust

Yash.Mahida@nottingham.ac.uk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026