Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02848040 |
| Other study ID # |
2016GAS85 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 2016 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
February 2024 |
| Source |
The Royal Wolverhampton Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
