Bile Acid Malabsorption
Conditions
Brief summary
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.
Interventions
DRUGOral chenodeoxycholic acid stimulation
oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
Sponsors
Lars Kristian Munck
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative predictive value of stimulated deltaFGF19 | Individual data are collected within one week | For screening purposes for bile acid diarrhoea. Negative Predictive Value by Receiver Operating Curve analysis for SeHCAT \< 10 % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 10% | Individual data are collected within one week | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT \<10% |
| Other diagnostic and Nosographic propabilities stimulated deltaFGF19, SeHCAT < 5% | Individual data are collected within one week | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by FGF19 for SeHCAT \<5% |
| Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <10% | Individual data are collected within one week | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT \<10% |
| Diagnostic and Nosographic propabilities of 7alpha-CHO for SeHCAT <5% | Individual data are collected within one week | Positive predictive value, sensitivity and specificity for bile acid diarrhoea judged by 7alpha-CHO for SeHCAT \<5% |
| Correlation of FGF19 to clinical diarrhoea | Individual data are collected within one week | Correlation of FGF19 (fasting and stimulated deltaFGF19) to diarrhoea by stool diary |
| Correlation of 7alpha-CHO to clinical diarrhoea | Individual data are collected within one week | Correlation of fasting 7alpha-CHO to diarrhoea by stool diary |
| FGF19 by SeHCAT stratum | Individual data are collected within one week | Median stimulated ∆FGF19 in SeHCAT stratum: 0-5%, \>5.1-10%, \>10.1-15%, \> 15.1%. |
| 7alpha-CHO by SeHCAT stratum | Individual data are collected within one week | Median fasting 7alpha-CHO in SeHCAT stratum: 0-5%, \>5.1-10%, \>10.1-15%, \> 15.1%. |
Countries
Denmark
Outcome results
None listed