Changes in stool habits and in the balance and regulation of bile acids after surgical removal of the gall bladder

Phase 1

• Conditions: Post cholecystectomy bile acid diarrhoea/malabsorption; MedDRA version: 19.1Level: PTClassification code 10069703Term: Bile acid malabsorptionSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.1Level: PTClassification code 10008611Term: CholecystectomySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.1Level: LLTClassification code 10066557Term: Chronic diarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.1Level: PTClassification code 10057229Term: Post cholecystectomy syndromeSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-004692-53-DK
• Lead Sponsor: Zealand University Hospital Køge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients between 18 and 80 yo. referred for elective cholcystectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Prior bowel resection. Known chronic diarrhoeal disease (coeliac disease, lactose malabsorption, any inflammatory bowel disease), pregnancy or desire for pregnancy, contraindications to Xenbilox or constituents in the capsule, allergy to eggs.
Chronic cholecystitis, recent (within 2 months) acute cholecystitis, known cirrosis, icterus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate changes in hormonal regulation (particularly by FGF19 and 7a-hydroxy-4-cholesten-3-one) and composition of the bile acid pool before and after elective cholecystectomy to deem the role of the intact gall bladder. ;Secondary Objective: Correlate changes in stool pattern correlated to the hormonal changes;Primary end point(s): change in xenbilox stimulated FGF19 (delta 150min - 0 min);Timepoint(s) of evaluation of this end point: Analysis of bloodsamples as soon as possible after LVLP, expected aprox. septemper 2017

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •change in plasma CDCA (chenodeoxycholic acid/xenbilox) absorption before vs after cholecystectomy (AUC)<br>•change in fasting and stimulated C4 before vs after cholecystectomy<br>•change in stool consistency before vs after cholecystectomy<br>•change in stool pattern correlated to changes in FGF19 and C4<br>•Comparing of ?FGF19 and fasting C4 between patients with normal stools and patients with diarrhoea.<br>•change in blood lipid status after cholecystectomy<br>•Change in abdominal symptoms and quality of life.<br>;Timepoint(s) of evaluation of this end point: same as above for primary endpoint