Ursodeoxycholic Acid in C. Difficile Infection | NCT05526807

Studies
Ursodeoxycholic Acid in C. Difficile Infection

NCT05526807

Sponsor

Nottingham University Hospitals NHS Trust

Status

Terminated

Last Update Posted

Apr 9, 2024Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Clostridioides Difficile Infection

Interventions

Ursodeoxycholic acid

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

May 8, 2019Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Aug 31, 2022

First Submission Date that Met QC Criteria

Aug 31, 2022

First Posted Date

Sep 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2024

Last Update Posted Date

Apr 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ursodeoxycholic acid	Experimental	Only one arm - subjects receiving ursodeoxycholic acid	Drug: Ursodeoxycholic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ursodeoxycholic acid	Drug	Oral	Ursodeoxycholic acid

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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)	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nottingham University Hospitals NHS Trust		Nottingham		NG7 2UH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014580	Ursodeoxycholic Acid

Ancestor Terms

ID	Term
D003840	Deoxycholic Acid
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided