Clinical trial NCT03168555: Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Official title: Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bile Acid Malabsorption
Cholelithiasis
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
Secondary outcomes:
measure: Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
measure: Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
measure: Change in Lipid Status From Baseline Before Versus After Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
measure: Change in Stool Frequency From Baseline Before Versus After Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
measure: Change in Stool Pattern Correlated to FGF19
timeFrame: baseline and 3 - 5 months after cholecystectomy
measure: Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
measure: Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy
timeFrame: before cholecystectomy and 3-5 months after cholecystectomy
measure: Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy
timeFrame: before and 3-5 months after cholecystectomy
measure: Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
measure: Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy
timeFrame: baseline and 3 - 5 months after cholecystectomy
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hosipital
name: Christian Borup
role: PRINCIPAL_INVESTIGATOR
References: