Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea

Summary

Bile acid diarrhoea is a chronic disease that impairs quality of life. One in 100 has the condition and many suffer from the disease without knowing. The current test is called SeHCAT and is expensive and time-consuming and is unavailable in many places, including the US. The disease is often misdiagnosed as irritable bowel syndrome and estimated one third of patients with irritable bowel syndrome of the mixed type and the diarrhoea predominant type suffer from bile acid diarrhoea without knowing. A blood test called 7α-hydroxy-4-cholestene-3-one (C4) could make it much easier to diagnose bile acid diarrhoea. To establish the new test, the results of both C4 and SeHCAT are compared with the treatment effect of the drug called colesevelam. We invite patients who are referred for the SeHCAT test to participate in the trial. The SeHCAT test takes two days that are one week apart. The study patients register stool habits with a diary in the week between the SeHCAT visits. Based on the diary results, we screen for eligibility; e.g. a certain degree/severity of diarrhoea is required for participation. We treat eligible study patients (i.e those with diarrhoea) with either colesevelam or placebo (medicine without effect) that is randomly assigned. 170 study patients need to complete the treatment. We aim to validate (ie. compare) both the C4-test and the SeHCAT test with the colesevelam treatment response as the reference.

Timeline

Start

2018-10-25

Primary completion

2021-07-01

Completion

2022-02-13

Publications

• Borup C, Vinter-Jensen L, Jorgensen SPG, Wildt S, Graff J, Gregersen T, Zaremba A, Andersen TB, Nojgaard C, Timm HB, Lamaziere A, Rainteau D, Hansen SH, Rumessen JJ, Munck LK. Prospective comparison of diagnostic tests for bile acid diarrhoea. Aliment Pharmacol Ther. 2024 Jan;59(1):39-50. doi: 10.1111/apt.17739. Epub 2023 Oct 5.
• Borup C, Vinter-Jensen L, Jorgensen SPG, Wildt S, Graff J, Gregersen T, Zaremba A, Borup Andersen T, Nojgaard C, Timm HB, Rainteau D, Hansen SH, Rumessen JJ, Munck LK. Efficacy and safety of colesevelam for the treatment of bile acid diarrhoea: a double-blind, randomised, placebo-controlled, phase 4 clinical trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):321-331. doi: 10.1016/S2468-1253(22)00401-0. Epub 2023 Feb 6.

Drugs

Indications