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

NCT02848040 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-01-06

No results posted yet for this study

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.

Conditions

  • Bowel Diseases

Interventions

OTHER

IDK Bile Acids

colourimetric in-vitro laboratory diagnostic test

Sponsors & Collaborators

  • The Royal Wolverhampton Hospitals NHS Trust

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848040 on ClinicalTrials.gov