Treatment of bile acid malabsorption with liraglutid

Phase 1

• Conditions: Bile acid malabsoprtion is a disease in which there is a large spill-over of bileacids to the larger intestines. This causes watery diarrheas and abdominal symptoms.; MedDRA version: 20.1Level: LLTClassification code 10080051Term: Bile acid diarrhoeaSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-003575-34-DK
• Lead Sponsor: Professor, Ph.d. MD. Filip Krag Knop

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-19
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Caucasian ethnicity
•SeHCAT-verified moderate (5–10% bile acid retention after 7 days) or severe type 2 BAM (<5% retention)
•Normal haemoglobin (for men 8.3-10.5 mmol/L; for women 7.3-9.5 mmol/L)
•Age above 18 years and below 75 years
•Informed and written consent
•BMI >18,5 kg/m2 and <40 kg/m2
•Glycated haemoglobin (HbA1c) <48 mmol/mol

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•History of or present hepatobiliary disorder (except for non-alcoholic steatotic liver disease) and/or alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3 times upper limit of normal) or history of hepatobiliary disorder
•Gastrointestinal disease (except for BAM), previous intestinal resection or any major intra-abdominal surgery
•Diabetes mellitus
•Nephropathy with eGFR < 30 mL/min/1.73m2
•Treatment with medicine that cannot be paused for 12 hours
•Hypothyroidism or hyperthyroidism, if not well regulated.
•Treatment with oral anticoagulants
•Active or recent malignant disease
•Any treatment or condition requiring acute or sub-acute medical or surgical intervention
•Female of child-bearing potential who is pregnant, breastfeeding or intend to become pregnant or is not using adequate contraceptive methods, which includes Intrauterine Device (IUD) og birth control pills.
•Known or suspected hypersensitivity to trial products or related products
•Any condition considered incompatible with participation by the investigators

Study & Design

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