Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.