Ursodeoxycholic Acid in C. Difficile Infection

April 8, 2024 updated by: Nottingham University Hospitals NHS Trust

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ursodeoxycholic acid
Only one arm - subjects receiving ursodeoxycholic acid
Drug: Ursodeoxycholic acid
Oral

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid
Time Frame: 12 weeks
Recurrence of C. difficile infection to be confirmed by stool test for toxin(s)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17GA025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clostridioides Difficile Infection

Clinical Trials on Ursodeoxycholic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe