The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- faecal bile acids retention values.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
faecal bile acids retention values.
时间窗: 12 weeks
SeHCAT retention values
时间窗: 12 weeks
次要结局
- measurement of bile salt sequestrants(12 weeks)
- measurement of faecal bile acids(12 weeks)
- excretion of faecal bile acids(12 weeks)