faecal bile acid study
The role of faecal bile acids in the management of bile acid diarrhoea.
Royal Wolverhampton NHS trust
Duration of Study in the UK
1 years, 3 months, 0 days
Background: The prevalence of chronic diarrhoea is 5% of the population, a third of these cases have bile acid malabsorption (BAM).
SeHCAT 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.
Aim: 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.
Methods: We will recruit patients (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: We will compare the results of faecal bile acid measurement in these patients 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 us to evaluate this new test in the NHS.
London - Stanmore Research Ethics Committee
Date of REC Opinion
18 Jul 2016