Phase 4 N=23 Diagnostic

Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy

Bile Acid Malabsorption · Cholelithiasis

Bottom Line

View on ClinicalTrials.gov: NCT03168555 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcome: Primary: Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy — 81; 186 pg per mL — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: chenodeoxycholic acid (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Zealand University Hospital
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Stimulated Fibroblast Growth Factor 19 (FGF19) From Baseline Before Versus Post Cholecystectomy	81; 186	0.03 sig
SECONDARY Change in Chenodeoxycholic Acid (CDCA) Absorption to Plasma From Baseline Before Versus After Cholecystectomy	1554; 1847	—
SECONDARY Change in Fasting 7-alpha-hydroxy-cholestenone (C4) From Baseline Before Versus After Cholecystectomy	6.0; 7.5	0.63
SECONDARY Change in Lipid Status From Baseline Before Versus After Cholecystectomy	1.4; 1.5	0.32
SECONDARY Change in Stool Frequency From Baseline Before Versus After Cholecystectomy	1.6; 1.6	0.73
SECONDARY Change in Stool Pattern Correlated to FGF19	-0.21	0.41
SECONDARY Change in Patient Reported Diarrhea Symptoms Correlated With Change in C4 From Baseline Before Versus After Cholecystectomy	-.23; -0.52	0.35
SECONDARY Change in C4 Total Area Under the Curve From Baseline Before Versus After Cholecystectomy	774; 1040	0.36
SECONDARY Change in Fasting FGF19 From Baseline Before Versus After Cholecystectomy	102; 92	0.29
SECONDARY Change in Patient Reported Diarrhea Symptoms Correlated With Change in FGF19 From Baseline Before Versus After Cholecystectomy	0.08; -0.07	0.73
SECONDARY Change in Stool Consistency (Bristol Stool Type) From Baseline Before Versus After Cholecystectomy	4.2; 4.0	0.80

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03168555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.