Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

Phase 4

Completed

Conditions: Bile Acid Malabsorption
Cholelithiasis

Interventions: Drug: chenodeoxycholic acid

Registration Number: NCT03168555

Lead Sponsor: Zealand University Hospital

Brief Summary: Investigate serial plasma samples of fibroblast growth factor 19 (FGF19) after oral stimulation with chenodeoxycholic acid in the same subjects before and after elective cholecystectomy

Detailed Description: Lack of FGF19 and elevated 7-alpha-hydroxy-colestenone (C4) is associated with the bile acid diarrhoea (BAD), a disease with increasing estimated of prevalence.

BAD is occasionally triggered by cholecystectomy and FGF19 and C4 is known to be affected by cholecystectomy. The investigators are exploring if FGF19 after oral stimulation can be developed to a universal test for BAD, and need to know how the proposed test is affected by cholecystectomy.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

Inclusion Criteria

planned elective cholecystectomy

Exclusion Criteria

small bowel resection
right sided hemicolectomy
known chronic diarrheal disease (celiac disease, lactose malabsorption, Inflammatory bowel diseases, incl microscopic colitis)
pregnancy
wish for pregnancy within next three months
allergy to eggs
allergy to constituents in Xenbilox (capsules with chenodeoxycholic acid)
acute cholecystitis within two months
chronic cholecystitis
cirrhosis of the liver
suspected obstructive choledocholithiasis
icterus

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	chenodeoxycholic acid	chenodeoxycholic acid 1250mg po.

Primary Outcome Measures

Name	Time	Method
Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Change from baseline to after cholecystectomy in median chenodeoxycholic acid (CDCA) plus meal stimulated FGF19 (delta 0 min to 150 min after stimulation)

Secondary Outcome Measures

Name	Time	Method
Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Change from baseline to after cholecystectomy in median unconjugated CDCA plus meal stimulated absorption of unconjugated CDCA to measured in plasma (total area under the CDCA curve with measurement at fasting ie. t=0 minutes and subsequently at 60, 90, 120, and finally at 150minutes.
Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Change from baseline to after cholecystectomy in fasting C4
Change in Lipid Status From Baseline Before Versus After Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Change from baseline to after cholecystectomy in plasma triglycerides
Change in Stool Pattern Correlated to FGF19	baseline and 3 - 5 months after cholecystectomy	Spearman correlation between change from baseline to after cholecystectomy in FGF19 and in mean number of stools
Change in Stool Frequency From Baseline Before Versus After Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Change from baseline to after cholecystectomy in number of stools as a mean of a seven-day diary baseline versus after cholecystectomy. That is the diary results for each study participant is tallied using mean values. The tallying of these diary results is done using medians. Therefore the unit used is 'mean stools per day' and this is reported with medians
Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting C4 before versus after cholecystectomy
Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy	before cholecystectomy and 3-5 months after cholecystectomy	Change in total AUC for C4 between visit 1 and visit 2
Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy	before and 3-5 months after cholecystectomy	change in fasting FGF19 before versus after cholecystectomy
Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Correlation between patient reported frequency of diarrhea (gastrointestinal quality of life index item 31) and fasting FGF19 before versus after cholecystectomy
Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy	baseline and 3 - 5 months after cholecystectomy	Change from baseline to after cholecystectomy in mean Bristol type per stool as of a seven-day diary baseline versus after cholecystectomy. The Bristol scale divides stool into seven categories from 1 (hard lumps) to 7 (completely watery stool). The diary shows pictograms with short text descriptions.