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Search / Trial NCT05738798

Oral Immunotherapy in Young Children With Food Allergy

Launched by DEVENTER ZIEKENHUIS · Feb 11, 2023

Trial Information

Current as of July 22, 2025

Enrolling by invitation

Keywords

Oral Immunotherapy Infants Food Allergy

ClinConnect Summary

Primary objective: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care? Secondary objective: What is the effect of early low-dose oral immunotherapy in children under the age of 30 months with an established food allergy on (allergy specific) quality of life of parents and children compared to routine care? Study design: randomized controlled superiority trial Study population: Children between 9 and 30 months old with an IgE-m...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • An IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow's milk and/or hen's egg as proven by sensitization to the specific allergen (sIgE \> 0.35kU/l) and a positive oral food challenge.
  • The fore-mentioned allergens are introduced into the diet of the child (the child is tolerant for the specific allergen(s)), or the child is diagnosed with a food allergy for the specific allergen(s).
  • Exclusion Criteria:
  • (Suspected) eosinophilic oesophagitis
  • Uncontrolled asthma/ viral wheeze.
  • The inability of parents to follow instructions, recognize allergic reactions or administer emergency medication.
  • Participation in any other intervention study at the time of the OIT study, with the exception of studies on guided early introduction of highly allergenic foods.

About Deventer Ziekenhuis

Deventer Ziekenhuis is a leading healthcare institution committed to advancing medical research and improving patient outcomes through innovative clinical trials. Located in Deventer, the Netherlands, the hospital integrates cutting-edge technology with a patient-centered approach to deliver high-quality care. As a clinical trial sponsor, Deventer Ziekenhuis actively collaborates with researchers and industry partners to facilitate the development of new therapies and treatment methodologies. Their focus on ethical standards, regulatory compliance, and rigorous scientific protocols ensures that all trials conducted under their auspices prioritize patient safety and contribute valuable insights to the medical community.

Locations

Delft, , Netherlands

Groningen, , Netherlands

Amsterdam, , Netherlands

Amsterdam, Noord Holland, Netherlands

Deventer, Overijssel, Netherlands

Patients applied

0 patients applied

Trial Officials

Ted Klok, MD PhD

Principal Investigator

Deventer Ziekenhuis

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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