Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

Study Overview
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Brief Summary
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This study aims to validate a possible diagnostic test for bile acid diarrhoea prospectively compared to the SeHCAT scintigraphy. Fasting participants are given a standard meal and 1,250 mg chenodeoxycholic acid. The investigators measure fasting FGF19, bile acids species including 7-alpha-CHO and serial blood samples after the stimulation.

Official Title
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Validation of Stimulated ∆FGF19 for Diagnosing Bile Acid Diarrhoea

Conditions
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Bile Acid Malabsorption

Intervention / Treatment
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* Drug: Oral chenodeoxycholic acid stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Consecutive patients referred for SeHCAT Exclusion Criteria: Treatment with sequestrants within one week before the SeHCAT. Treatment with any constipants/laxatives one day before the SeHCAT, with the exception of opioids, if the dosis has been stable in the prior 2 weeks. Pregnancy, screening by pregnancy test before inclusion. Breastfeeding women. Small bowel resection, including right sided hemicolectomy. Any ongoing treatment for inflammatory bowel disease with systemic steroids (i.e. budesonide or prednisone) or treatment in the prior 4 weeks. Allergies to constituents of Xenbilox: (chenodeoxycholic acid, cornflour, magnesium stearate, highly dispersed silica, gelatine, sodium dodecylsulphate, titanium dioxide (E171), quinolone yellow (E104), erythrosine (E127) Chronic or acute cholecystitis. Liver cirrhosis, Obstructed bile flow causing jaundice or elevated p-bilirubin (> 1,5 UNL). Known disability in gall bladder contractility. Bile duct atresia. Frequent gallstone attacks (>2/month).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation Test<br>Study meal plus chenodeoxycholic acid: 1,250 mg single dose stimulation | Drug: Oral chenodeoxycholic acid stimulation<br>* oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor<br>* Other names: Chenodeoxycolic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of stimulated deltaFGF19 | For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT < 10 % | Individual data are collected within one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10% | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <10% | Individual data are collected within one week | 
| Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5% | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT <5% | Individual data are collected within one week | 
| Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10% | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <10% | Individual data are collected within one week | 
| Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5% | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT <5% | Individual data are collected within one week | 
| Correlation of FGF19 to clinical diarrhoea | Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary | Individual data are collected within one week | 
| Correlation of 7alpha-CHO to clinical diarrhoea | Correlation of fasting 7alpha-CHO to diarrhoea by stool diary | Individual data are collected within one week | 
| FGF19 by SeHCAT stratum | Median stimulated ∆FGF19 in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%. | Individual data are collected within one week | 
| 7alpha-CHO by SeHCAT stratum | Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, >5.1-10%, >10.1-15%, > 15.1%. | Individual data are collected within one week |