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Search / Trial NCT06179121

"Adding DNA-test for Screening of HLA-DQ2 and DQ8 to Improve Early Diagnosis of Celiac Disease"

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Dec 12, 2023

Trial Information

Current as of July 28, 2025

Enrolling by invitation

Keywords

Coeliac Disease Preventive Youth Health Care Center

ClinConnect 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 characterized by a variable combination of gluten-dependent clinical manifestations, CD specific antibodies, human leukocyte antigen (HLA)-DQ2 or HLA-DQ8 haplotypes and chronic inflammation of the small bowel\[1,2\]. T-cells in the lamina propria of the small bowel recognize the gluten peptides when they are bound to the HLA class II specificities DQ2 and/or DQ8 on antigen-presenting cells.

CD is one of t...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • Phase 1 and 2:
  • no informed consent,
  • insufficient knowledge of Dutch language and/or inability to understand the information provided,
  • bleeding disorders.

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Leiden, South Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Caroline R Meijer-Boekel, PhD

Principal Investigator

Leiden University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported