- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848040
The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Midlands
-
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
- The Royal Wolverhampton NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
All patients will receive the same interventions.
Single are only
|
colourimetric in-vitro laboratory diagnostic test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
faecal bile acids retention values.
Time Frame: 12 weeks
|
12 weeks
|
SeHCAT retention values
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measurement of faecal bile acids
Time Frame: 12 weeks
|
Sensitivity and specificity of positive and negative predictive values
|
12 weeks
|
measurement of bile salt sequestrants
Time Frame: 12 weeks
|
descriptive prediction on the response to treatment
|
12 weeks
|
excretion of faecal bile acids
Time Frame: 12 weeks
|
descriptive prediction on the response to treatment
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
- A single faecal bile acid stool test demonstrates potential efficacy in replacing SeHCAT testing for bile acid diarrhoea in selected patients
- The impact of bile acid sequestrants on quality of life in patients with bile acid diarrhoea.
- Pre-analytical DNA yield and variability influences microbiome laboratory analyses: is it time for a unified international consensus for optimal sampling and DNA isolation?
- The analysis of gut microbiota in patients with bile acid diarrhoea treated with colesevelam.
- Bile acids and the gut microbiome in post-operative Crohn's disease: a mechanistic relationship?
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016GAS85
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bowel Diseases
-
Medtronic - MITGCompletedInflammatory Bowel Disease | Small Bowel DiseaseUnited States
-
University of British ColumbiaCompletedInflammatory Bowel Disease 11Canada
-
University of ChicagoTerminatedInflammatory Bowel Disease (IBD)United States
-
Centre Hospitalier Universitaire, AmiensFunding from DGOS (PHRC IR 2013 and PRME)CompletedPediatric Inflammatory Bowel DiseaseFrance
-
University of Wisconsin, MadisonTerminatedInflammatory Bowel Disease (IBD)United States
-
Cedars-Sinai Medical CenterUnknownPediatric Inflammatory Bowel Disease
-
ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
University of Wisconsin, MadisonCompletedInflammatory Bowel Disease (IBD)United States
-
Assiut UniversityNot yet recruitingIBD-Inflammatory Bowel Disease
-
University of LouisvilleCompletedIrritable Bowel DiseaseUnited States
Clinical Trials on IDK Bile Acids
-
Mayo ClinicSatiogen Pharmaceuticals, Inc.CompletedOverweight | Type 2 Diabetes Mellitus | ObeseUnited States
-
Swedish Orphan BiovitrumTerminatedPrevention of Growth RestrictionBelgium, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Czech Republic, Russian Federation
-
Children's Hospital Medical Center, CincinnatiNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Galmed Medical ReserchCompleted
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrolling by invitationHealthy | ObesityUnited States
-
University Hospital, Basel, SwitzerlandCompleted
-
University of AarhusGE Healthcare; Danish Cancer SocietyCompletedDiarrhea | Colon AdenocarcinomaDenmark
-
Hvidovre University HospitalWithdrawn
-
Karolinska InstitutetKarolinska University Hospital; University Hospital, Linkoeping; Danderyd Hospital and other collaboratorsTerminated
-
CHU de ReimsCompletedCholangiocarcinoma, Cancer of the Head of the PancreasFrance