Treatment effect of colesevelam for bile acid diarrhoea

Phase 1

• Conditions: Bile acid diarrhoea; MedDRA version: 20.1Level: PTClassification code 10069703Term: Bile acid malabsorptionSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1Level: LLTClassification code 10066557Term: Chronic diarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-001452-22-DK
• Lead Sponsor: Zealand University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-09
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

•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

Exclusion Criteria

•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
•Pregnancy
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified