Status:
UNKNOWN
"Adding DNA-test for Screening of HLA-DQ2 and DQ8 to Improve Early Diagnosis of Celiac Disease"
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Celiac Disease in Children
Eligibility:
All Genders
12-18 years
Brief Summary
Celiac Disease (CD) is an immune-mediated systemic disorder elicited by the ingestion of gluten containing cereals from the normal diet, among others wheat, rye and barley. The disease is characterize...
Detailed Description
Celiac Disease (CD) is an immune-mediated systemic disorder elicited by the ingestion of gluten containing cereals from the normal diet, among others wheat, rye and barley. The disease is characterize...
Eligibility Criteria
Inclusion
- Phase 1:
- age 1-18 years,
- consultation at the LUMC for (suspicion of) CD,
- parents have a sufficient knowledge of Dutch language,
- written informed consent from child and/or parent
- Phase 2:
- age 12 months to 4 years,
- at least one of the 10 CD-related symptoms
- not diagnosed with CD,
- not on a GFD,
- parents have a sufficient knowledge of Dutch language,
- written informed consent from the parent(s)
Exclusion
- Phase 1 and 2:
- no informed consent,
- insufficient knowledge of Dutch language and/or inability to understand the information provided,
- bleeding disorders.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT06179121
Start Date
September 1 2022
End Date
November 1 2024
Last Update
December 21 2023
Active Locations (1)
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1
Leiden University Medical Centre (LUMC)
Leiden, South Holland, Netherlands, 2333 ZA