Changes in Bile Acid Homeostasis and Stool Habits After Cholecystectomy (BACH)

Zealand University Hospital

Status and phase: Completed; Phase 4

Conditions: Cholelithiasis; Bile Acid Malabsorption

Treatments: Drug: chenodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03168555

2016-004692-53 (EudraCT Number)

SJ-434

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Intervention

Experimental group

Description:

chenodeoxycholic acid 1250mg po.

Treatment:

Drug: chenodeoxycholic acid