The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea

February 13, 2024 updated by: The Royal Wolverhampton Hospitals NHS Trust

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

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimated)

July 28, 2016

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2016GAS85

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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