Trial to validate a method based on a blood sample to diagnose the disease bile acid diarrhoea

Phase 1

• Conditions: Bile acid malabsorption / bile acid diarrhoea; MedDRA version: 19.1Level: PTClassification code 10069703Term: Bile acid malabsorptionSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 19.1Level: LLTClassification code 10066557Term: Chronic diarrhoeaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2016-002217-22-DK
• Lead Sponsor: Sjællands University Hospital, Køge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-03
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

referral to SeHCAT for investigation of chronic watery diarrhoea
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Treatment with sequestrants or constipants/laxatives within one week before the SeHCAT. Pregnancy. Small bowel resection. Untreated active small bowel disease such as Crohns’ disease. Age < 18 years or > 80 years.

Study & Design

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