Treatment effect of colesevelam for bile acid diarrhoea - SINBAD

Zealand University Hospital0 个研究点目标入组 170 人开始时间: 2017年6月9日最近更新: 2022年8月8日

试验速览

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•Patients with suspected bile acid diarrhoea referred for SeHCAT retention test at Holbæk, Hvidovre, Aarhus, or Aalborg university hospitals
•age >= 18yo. and < 80 yo.
•Women of fertile age must use safe contraception during the study as specified in the protocol
•Ability to give informed consent after written and oral information in Danish language
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Inflammatory bowel disease, including microscopic colitis
•Investigator assessed debilitating chronic disease (WHO performance score 3-5)
•Prior treatment with colesevelam
•Treatment with laxatives or constipants during the study
•oExcept 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
•oi.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
•Acute suspected or proven viral gastroenteritis within the recent 4 weeks
•Acute non-viral gastroenteritis within the recent 8 weeks

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