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Ursodeoxycholic Acid in C. Difficile Infection

Primary Purpose

Clostridioides Difficile Infection

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ursodeoxycholic acid
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridioides Difficile Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Nottingham University Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ursodeoxycholic acid

Arm Description

Only one arm - subjects receiving ursodeoxycholic acid

Outcomes

Primary Outcome Measures

To assess tolerability to oral ursodeoxycholic acid
Assess for side effects

Secondary Outcome Measures

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)

Full Information

First Posted
August 31, 2022
Last Updated
September 6, 2022
Sponsor
Nottingham University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05526807
Brief Title
Ursodeoxycholic Acid in C. Difficile Infection
Official Title
Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridioides Difficile Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ursodeoxycholic acid
Arm Type
Experimental
Arm Description
Only one arm - subjects receiving ursodeoxycholic acid
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Intervention Description
Oral
Primary Outcome Measure Information:
Title
To assess tolerability to oral ursodeoxycholic acid
Description
Assess for side effects
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid
Description
Recurrence of C. difficile infection to be confirmed by stool test for toxin(s)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yashwant Mahida
Phone
441159249924
Email
yash.mahida@nottingham.ac.uk
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yashwant Mahida
Phone
+441159249924
Email
yash.mahida@nottingham.ac.uk

12. IPD Sharing Statement

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Ursodeoxycholic Acid in C. Difficile Infection

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