Clostridioides Difficile InfectionNCT05526807
Ursodeoxycholic Acid in C. Difficile Infection
A study testing Ursodeoxycholic acid in people with Clostridioides Difficile Infection, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- Ursodeoxycholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days
Who cannot join
- • 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
Official title: 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
- Conditions
- Clostridioides Difficile Infection
- Being tested
- Ursodeoxycholic acid
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Ursodeoxycholic acid | Experimental | Only one arm - subjects receiving ursodeoxycholic acid Receives: Drug: Ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess tolerability to oral ursodeoxycholic acid
Assess for side effects
Measured: 6 weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start8 May 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526807
- Sponsor's protocol ID
- 17GA025
- Status last verified
- Apr 2024
- First submitted
- 31 Aug 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Studies to Investigate the Role of Ursodeoxycholic Acid in the Prevention of Recurrence of C. Difficile Infection
- ClinicalTrials.gov ID
- NCT05526807
- Acronym / sponsor ID
- 17GA025
- Conditions
- Clostridioides Difficile Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ursodeoxycholic acid | Experimental | Drug: Ursodeoxycholic acidOnly one arm - subjects receiving ursodeoxycholic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days
Key exclusion criteria (10 listed)
- • Pregnant or Breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic acidOral | Drug | Ursodeoxycholic acid |
Primary outcome
To assess tolerability to oral ursodeoxycholic acid
Time frame: 6 weeks
Assess for side effects
1 secondary outcome
To determine recurrence of C. difficile infection in those able to take ursodeoxycholic acid
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic acid in people with Clostridioides Difficile Infection, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess tolerability to oral ursodeoxycholic acid (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024; AzTrials last refreshed its copy on 27 Oct 2026.