Ursodeoxycholic Acid in C. Difficile Infection

NCT ID: NCT05526807

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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Clostridioides Difficile Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ursodeoxycholic acid

Only one arm - subjects receiving ursodeoxycholic acid

Group Type EXPERIMENTAL

Ursodeoxycholic acid

Intervention Type DRUG

Oral

Interventions

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Ursodeoxycholic acid

Oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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17GA025

Identifier Type: -

Identifier Source: org_study_id

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