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Efficacy and Safety of Colesevelam for the Treatment of Bile Acid Diarrhoea: a Double-blind, Randomised, Placebo-controlled, Phase 4 Clinical Trial by Christian Borup; Lars Vinter-Jensen; Søren Peter German Jørgensen; Signe Wildt; Jesper Graff; Tine Gregersen; Anna Zaremba; Trine Borup Andersen; Camilla Nøjgaard; Hans Bording Timm; Dominique Rainteau; Svend Høime Hansen; Jüri Johannes Rumessen; Lars Kristian Munck is a Medicine article available to read on EtoBox.
What is Efficacy and Safety of Colesevelam for the Treatment of Bile Acid Diarrhoea: a Double-blind, Randomised, Placebo-controlled, Phase 4 Clinical Trial about?
Background Bile acid diarrhoea is a common but overlooked cause of chronic watery diarrhoea. Plasma 7α-hydroxy-4-cholesten-3-one (C4) is an alternative to the gold standard tauroselcholic [75Se] acid (SeHCAT) test. Low-certainty evidence supports sequestrant treatment, including colesevelam. We aimed to determine the efficacy and safety of colesevelam in bile acid diarrhoea. Methods In this randomised, double-blind, placebo-controlled, investigator-initiated phase 4 trial of the sequestrant colesevelam in bile acid diarrhoea (SINBAD), we enrolled consecutive patients aged 18–79 years without inflammatory bowel disease attending SeHCAT testing for suspected bile acid diarrhoea at four Danish secondary care centres. Participants were randomly allocated 1:1 to receive 12 days of treatment with colesevelam (overencapsulated tablets of 625 mg) or placebo, with the starting dose of two capsules twice daily and titrated to effect during the first 5 days of treatment. A pharmacist independent of the clinical investigators generated a randomisation list on the web page randomization.com using block randomisation (randomisation was not stratified). C4 and SeHCAT diagnostic results were blind
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- Author
- Christian Borup; Lars Vinter-Jensen; Søren Peter German Jørgensen; Signe Wildt; Jesper Graff; Tine Gregersen; Anna Zaremba; Trine Borup Andersen; Camilla Nøjgaard; Hans Bording Timm; Dominique Rainteau; Svend Høime Hansen; Jüri Johannes Rumessen; Lars Kristian Munck
- Publisher
- Elsevier BV
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)