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

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ClinicalTrials.gov Identifier: NCT02848040
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
The Royal Wolverhampton Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Bowel Diseases Other: IDK Bile Acids Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Faecal Bile Acids in the Management of Bile Acid Diarrhoea
Actual Study Start Date : December 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Arm
All patients will receive the same interventions. Single are only
Other: IDK Bile Acids
colourimetric in-vitro laboratory diagnostic test




Primary Outcome Measures :
  1. faecal bile acids retention values. [ Time Frame: 12 weeks ]
  2. SeHCAT retention values [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. measurement of faecal bile acids [ Time Frame: 12 weeks ]
    Sensitivity and specificity of positive and negative predictive values

  2. measurement of bile salt sequestrants [ Time Frame: 12 weeks ]
    descriptive prediction on the response to treatment

  3. excretion of faecal bile acids [ Time Frame: 12 weeks ]
    descriptive prediction on the response to treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848040


Contacts
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Contact: Matthew Brookes matthew.brookes@nhs.net

Locations
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United Kingdom
The Royal Wolverhampton NHS Trust Recruiting
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
Contact: Matthew Brookes       matthew.brookes@nhs.net   
Sponsors and Collaborators
The Royal Wolverhampton Hospitals NHS Trust

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Responsible Party: The Royal Wolverhampton Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02848040     History of Changes
Other Study ID Numbers: 2016GAS85
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Bile Acids and Salts
Gastrointestinal Agents