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

Changes in bile acid homeostasis and stool habits after cholecystectomy - BACH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004692-53-DK

Enrollment

Registered

2017-01-11

Start date

2017-03-01

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post cholecystectomy bile acid diarrhoea/malabsorption MedDRA version: 19.1 Level: PT Classification code 10069703 Term: Bile acid malabsorption System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.1 Level: PT Classification code 10008611 Term: Cholecystectomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.1 Level: LLT Classification code 10066557 Term: Chronic diarrhoea System Organ Class: 10017947 - Gastrointestinal disorders MedDR

Interventions

Trade Name: Xenbilox Product Name: Xenbilox Product Code: PZN: 05484764 Pharmaceutical Form: Capsule, hard INN or Proposed INN: CHENODEOXYCHOLIC ACID CAS Number: 474-25-9 Current Sponsor code: Xenbilo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

—

Countries

Denmark

Contacts

Public ContactDepartment of Medicine

Zealand University Hospital Køge

chrbo@regionsjaelland.dk004547322400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026