Status:
COMPLETED
Effect of the Sequestrant Colesevelam in Bile Acid Diarrhoea
Lead Sponsor:
Lars Kristian Munck
Collaborating Sponsors:
Pierre and Marie Curie University
Conditions:
Bile Acid Malabsorption
Chronic Diarrhea
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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...
Detailed Description
ISSUE Bile Acid Diarrhoea (BAD) affects 1% of the general population and many people live with the disease and the impaired quality of life it causes without knowing it. The current scintigraphic sele...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2022
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT03876717
Start Date
October 25 2018
End Date
February 13 2022
Last Update
August 23 2022
Active Locations (4)
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1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Aarhus University Hospital
Aarhus, Denmark, 8200
3
Hvidovre University Hospital
Hvidovre, Denmark, 2650
4
Zealand University Hospital
Køge, Denmark, 4600