Bowel DiseasesNCT02848040
The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea
A study testing IDK Bile Acids in people with Bowel Diseases, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Bile acid malabsorption (BAM), a common cause of diarrhoea, affects 1 million people in the UK, but is often misdiagnosed as irritable bowel syndrome or goes unrecognised in patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Diseases
- What is being tested?
- IDK Bile Acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to 31 Dec 2021
- 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
- 18 years age and over
- Willing to provide informed consent
- Post-cholecystectomy patients group (n=30; type 3 BAD)
- Post-terminal ileal resection patients with Crohn's disease group (n=30; type 1 BAD)
- D-IBS patients with normal SeHCAT retention group (n=30)
- Idiopathic bile salt diarrhoea with abnormal SeHCAT retention group (type 2 BAD) (n=30)
Who cannot join
- Pregnancy/ breast feeding
- Patient participating in another trial
- Patients unable to give written consent
- Known established bile salt diarrhoea
- Recipients of antibiotics in under 4 weeks of initial trial participation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
About this study
Bile acid malabsorption (BAM), a common cause of diarrhoea, affects 1 million people in the UK, but is often misdiagnosed as irritable bowel syndrome or goes unrecognised in patients with inflammatory bowel disease.
The SeHCAT (seleno-tauro-homocholic acid) test is currently the only diagnostic test for BAM, but it is not widely available and it is also time consuming, expensive and involves exposure to radioactivity. Some clinicians give a course of blind or empirical treatment instead. The National Institute of Clinical Excellence (NICE) recognised these issues and highlighted the need for cheaper and safer tests to identify BAM.
This study will assess the accuracy of a simple, convenient and inexpensive laboratory test for the rapid diagnosis of BAM which measures bile acids in stool. This test has the potential to have a broad impact on clinical practice and patient care by enabling doctors to identify and treat patients with BAM promptly. Results from the second phase of the study will allow the assessment of the benefits of monitoring the stool test to determine whether the bile acid changes can predict the response to treatment and dosage needed for each patient.
Read the detailed description
The prevalence of chronic diarrhoea is 5% of the population, a third of these cases have bile acid malabsorption (BAM).
SeHCAT (seleno-tauro-homocholic acid) testing is the gold standard for BAM, and involves the ingestion of seleno-tauro-homocholic acid, which is limited to a small number of UK centres. NICE reported that although SeHCAT might benefits patients, there was a need to explore alternative technologies.
With limited access to and cost of SeHCAT, many centres use an empirical trial of bile acid sequestrants, without a diagnosis. This may not be effective as many patients are non-adherent.
This pilot study will evaluate a cheaper and simpler laboratory test, which quantitates faecal bile acids. This assay is safer, easier to use, and potentially gives a rapid diagnosis in BAM. The aim is to determine the sensitivity and specificity of this new assay. In the longitudinal phase of this study, further evaluate of faecal bile acids following bile salt sequestrant therapy, will evaluate its role in dose titration.
The following patients will be recruited (i) post-cholecystectomy; (ii) post-terminal ileal resection; or (iii) primary BAM. Patients will have SeHCAT testing and the faecal bile acid concentration will be determined.
Outcomes: The results of faecal bile acid measurement in these patients will be compared with SeHCAT to determine its sensitivity and specificity. Longitudinal follow up will determine the effect of bile salt sequestration on faecal bile acids. These results would inform the design of larger studies, allowing the evaluation of this new test in the NHS.
- Conditions
- Bowel Diseases
- Being tested
- IDK Bile Acids
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDK Bile AcidsOther
colourimetric in-vitro laboratory diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients will receive the same interventions. Single are only Receives: Other: IDK Bile Acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
faecal bile acids retention values.
Measured: 12 weeks
SeHCAT retention values
Measured: 12 weeks
Secondary outcomes (3)
measurement of faecal bile acids
Sensitivity and specificity of positive and negative predictive values
Measured: 12 weeks
measurement of bile salt sequestrants
descriptive prediction on the response to treatment
Measured: 12 weeks
excretion of faecal bile acids
descriptive prediction on the response to treatment
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 posted28 Jul 2016 (estimated)
- Study startDec 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DiseasesStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848040
- Sponsor's protocol ID
- 2016GAS85
- Status last verified
- Jan 2025
- First submitted
- 20 Jul 2016
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea
- ClinicalTrials.gov ID
- NCT02848040
- Acronym / sponsor ID
- 2016GAS85
- Conditions
- Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- Dec 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
Bile acid malabsorption (BAM), a common cause of diarrhoea, affects 1 million people in the UK, but is often misdiagnosed as irritable bowel syndrome or goes unrecognised in patients with inflammatory bowel disease.
The SeHCAT (seleno-tauro-homocholic acid) test is currently the only diagnostic test for BAM, but it is not widely available and it is also time consuming, expensive and involves exposure to radioactivity. Some clinicians give a course of blind or empirical treatment instead. The National Institute of Clinical Excellence (NICE) recognised these issues and highlighted the need for cheaper and safer tests to identify BAM.
This study will assess the accuracy of a simple, convenient and inexpensive laboratory test for the rapid diagnosis of BAM which measures bile acids in stool. This test has the potential to have a broad impact on clinical practice and patient care by enabling doctors to identify and treat patients with BAM promptly. Results from the second phase of the study will allow the assessment of the benefits of monitoring the stool test to determine whether the bile acid changes can predict the response to treatment and dosage needed for each patient.
Detailed description
The prevalence of chronic diarrhoea is 5% of the population, a third of these cases have bile acid malabsorption (BAM).
SeHCAT (seleno-tauro-homocholic acid) testing is the gold standard for BAM, and involves the ingestion of seleno-tauro-homocholic acid, which is limited to a small number of UK centres. NICE reported that although SeHCAT might benefits patients, there was a need to explore alternative technologies.
With limited access to and cost of SeHCAT, many centres use an empirical trial of bile acid sequestrants, without a diagnosis. This may not be effective as many patients are non-adherent.
This pilot study will evaluate a cheaper and simpler laboratory test, which quantitates faecal bile acids. This assay is safer, easier to use, and potentially gives a rapid diagnosis in BAM. The aim is to determine the sensitivity and specificity of this new assay. In the longitudinal phase of this study, further evaluate of faecal bile acids following bile salt sequestrant therapy, will evaluate its role in dose titration.
The following patients will be recruited (i) post-cholecystectomy; (ii) post-terminal ileal resection; or (iii) primary BAM. Patients will have SeHCAT testing and the faecal bile acid concentration will be determined.
Outcomes: The results of faecal bile acid measurement in these patients will be compared with SeHCAT to determine its sensitivity and specificity. Longitudinal follow up will determine the effect of bile salt sequestration on faecal bile acids. These results would inform the design of larger studies, allowing the evaluation of this new test in the NHS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Other: IDK Bile AcidsAll patients will receive the same interventions. Single are only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years age and over
- Willing to provide informed consent
- Post-cholecystectomy patients group (n=30; type 3 BAD)
- Post-terminal ileal resection patients with Crohn's disease group (n=30; type 1 BAD)
- D-IBS patients with normal SeHCAT retention group (n=30)
Key exclusion criteria (5 listed)
- Pregnancy/ breast feeding
- Patient participating in another trial
- Patients unable to give written consent
- Known established bile salt diarrhoea
- Recipients of antibiotics in under 4 weeks of initial trial participation
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 |
|---|---|---|
| IDK Bile Acidscolourimetric in-vitro laboratory diagnostic test | Other | Single Arm |
Primary outcome
faecal bile acids retention values.
Time frame: 12 weeks
SeHCAT retention values
Time frame: 12 weeks
3 secondary outcomes
measurement of faecal bile acids
Time frame: 12 weeks
measurement of bile salt sequestrants
Time frame: 12 weeks
excretion of faecal bile acids
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- A single faecal bile acid stool test demonstrates potential efficacy in replacing SeHCAT testing for bile acid diarrhoea in selected patientsLink provided by the sponsor.
- The impact of bile acid sequestrants on quality of life in patients with bile acid diarrhoea.Link provided by the sponsor.
- Pre-analytical DNA yield and variability influences microbiome laboratory analyses: is it time for a unified international consensus for optimal sampling and DNA isolation?Link provided by the sponsor.
- The analysis of gut microbiota in patients with bile acid diarrhoea treated with colesevelam.Link provided by the sponsor.
- Bile acids and the gut microbiome in post-operative Crohn's disease: a mechanistic relationship?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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 IDK Bile Acids in people with Bowel Diseases, run by The Royal Wolverhampton 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 6 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
faecal bile acids retention values. (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 6 Jan 2025.