Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lars Kristian Munck
• Collaborator: Pierre and Marie Curie University
• Treatments: Bile Acids and Salts; Colesevelam Hydrochloride

Criteria

Inclusion Criteria:

• Patient referred to Clinical Physiological/Nuclear Medicine departments for SeHCAT

• Suspected Bile acid diarrhoea

• Age > 18 years and under 80 years

• women of fertile age must use safe contraception during the treatment part of the study

• Ability to give informed consent after written and oral information in Danish language

Exclusion Criteria:

• Inflammatory bowel disease, including microscopic colitis

• Investigator assessed debilitating chronic disease e.g. World Health Organisation performance score 3-5

• Prior treatment with colesevelam

• Treatment with laxatives or anti-diarrhoeal drugs during the study

• Except for stable dose the last four weeks of psyllium husk and opioids for pain

• Breastfeeding women

• Crucial medication that cannot be separated appropriately from colesevelam

• i.e. taken one hour before or 4 hours after colesevelam

• Oral anticoagulation, both warfarin, and new oral anticoagulation

• Treatment with cyclosporine within two months

• Bowel obstruction (subileus or ileus)

• Biliary obstruction

• Short bowel syndrome

• Bowel ostomy

• Allergy to colesevelam or its constituents

• Allergy to placebo constituents (excluding lactose)

• Investigator assessed high risk of non-compliance

• If on statin/fibrate medication, unwilling to pause medication between study visits 1 and 2