NCT05526807

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

4.7 years

First QC Date

August 31, 2022

Last Update Submit

April 8, 2024

Conditions

Clostridioides Difficile Infection

Outcome Measures

Primary Outcomes (1)

  • To assess tolerability to oral ursodeoxycholic acid

    Assess for side effects

    6 weeks

Secondary Outcomes (1)

  • To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid

    12 weeks

Study Arms (1)

Ursodeoxycholic acid

EXPERIMENTAL

Only one arm - subjects receiving ursodeoxycholic acid

Drug: Ursodeoxycholic acid

Interventions

Ursodeoxycholic acidDRUG

Oral

Ursodeoxycholic acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

May 8, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

GB(1)