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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
71
oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Zealand University Hopsital
Holbæk, Denmark
Hvidovre University Hospital
Hvidovre, Denmark
Zealand University Hospital
Negative predictive value of stimulated deltaFGF19
For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT \< 10 %
Time frame: Individual data are collected within one week
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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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
Time frame: Individual data are collected within one week
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Køge, Denmark
Correlation of 7alpha-CHO to clinical diarrhoea
Correlation of fasting 7alpha-CHO to diarrhoea by stool diary
Time frame: 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%.
Time frame: 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%.
Time frame: Individual data are collected within one week