51. Protocol for a randomised, double-blinded, placebo-controlled, double-dummy 6-week clinical trial comparing the treatment effects of the glucagon-like peptide 1 receptor agonist liraglutide versus the bile acid sequestrant colesevelam on bile acid malabsorption
- Author
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Julie Lyng Forman, Anne Haaber, Martin L. Kårhus, David P. Sonne, Filip K. Knop, Tina Vilsbøll, and Andreas Brønden
- Subjects
Adult ,medicine.medical_specialty ,malabsorption ,medicine.drug_class ,Colesevelam Hydrochloride ,gastroenterology ,Gastroenterology and Hepatology ,hepatobiliary disease ,Bile Acids and Salts ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Double-Blind Method ,Glucagon-Like Peptide 1 ,Bile acid sequestrant ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,media_common.cataloged_instance ,030212 general & internal medicine ,European union ,Hypolipidemic Agents ,Randomized Controlled Trials as Topic ,media_common ,clinical trials ,Bile acid ,Colesevelam ,business.industry ,Hepatobiliary disease ,Bile acid malabsorption ,General Medicine ,Liraglutide ,medicine.disease ,chemistry ,Medicine ,030211 gastroenterology & hepatology ,SeHCAT ,business ,medicine.drug - Abstract
IntroductionBile acid malabsorption (BAM) is a socially debilitating disease characterised by high stool frequency and urgency caused by a spillover of bile acids into the colon. Bile acid sequestrants (BASs) have limited therapeutic effect but represent the only available treatment option. Cases reporting total remission of BAM-related symptoms after treatment with liraglutide, a glucagon-like peptide 1 analogue, prompted us to design a clinical trial investigating the therapeutic effect of this compound in patients with BAM.Methods and analysisFifty adult individuals with moderate or severe BAM as assessed by the 75selenium-homotaurocholic acid test (SeHCAT) will, after a run-in period of 10 days with no BAM treatment, be randomised to either treatment with the BAS colesevelam or liraglutide (double blinded) for 6 weeks. Daily symptom diaries and questionnaires will be filled in. Blood and faecal samples will be collected and SeHCAT will be performed at baseline, after week 3 and at end of trial. The primary endpoint is change in daily stool frequency. Secondary endpoints include changes from baseline in questionnaires, biochemistry, SeHCAT and faecal bile acid content and microbial composition.Ethics and disseminationThe study complies with Danish and European Union legislation and is approved by the Danish Medicines Agency, the Regional Scientific Ethics Committee of the Capital Region of Denmark and the Danish Data Protection Agency. The study is monitored by the Capital Region of Denmark’s good clinical practice unit. All results, positive, negative and inconclusive, will be disseminated at national and/or international scientific meetings and in peer-reviewed scientific journals.Trial registration numberEudraCA: 2018-003575-34; Pre-results.
- Published
- 2021