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

NCT02848040 | Completed DMC

• 1 other identifier: 2016GAS85
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• faecal bile acids retention values.

  12 weeks

• SeHCAT retention values

  12 weeks

Secondary Outcomes (3)

• measurement of faecal bile acids

  12 weeks

• measurement of bile salt sequestrants

  12 weeks

• excretion of faecal bile acids

  12 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

All patients will receive the same interventions. Single are only

Other: IDK Bile Acids

Interventions

IDK Bile Acids OTHER

colourimetric in-vitro laboratory diagnostic test

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

Location

Related 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?

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 28, 2016
• Study Start: December 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)