Prospective multicentre trial of Antibody diagnostics in paediatric Coeliac Disease

• Conditions: K90.0; Coeliac disease

• Registration Number: DRKS00003854
• Lead Sponsor: niversität LeipzigInstitut für Laboratoriumsmedizin, Klinische Chemie und Molekulare Diagnostik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-10
• Study Completion: 2016-07-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 949

Inclusion Criteria

• Children and adolescents scheduled for duodenal biopsy as by standard clinical practice with primary aim to confirm (or refute) CD
• Age 5 months to < 18 years
• Written informed consent of the patient’s parents

Exclusion Criteria

• Former diagnosis of CD
• GFD within the last 8 weeks
• Immunosuppressive therapy within the last 8 weeks
• Suspected lack of compliance
• Participation in other interventional trials

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnosis based on the current standard will be compared to that of the proposed diagnostic cascade” (which will not generally include a biopsy). Only the first assessment of the tissue sample will be utilized for the current standard.