Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea (NCT03876717) | Clinical Trial Compass
CompletedPhase 4
Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea
Denmark255 participantsStarted 2018-10-25
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intention-to-treat diarrhoea remission rate defined by the Hjortswang criteria for colesevelam in patients with BAD defined by C4 > 46 ng/mL
Timeframe: Intervention days 6 through 12 (last seven intervention days)