Clinical Trial

Oral Immunotherapy in Young Children With Food Allergy

Study acronym: ORKA-NL
Enrolling by Invitation
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Summary
The goal of this clinical trial is to learn about oral immunotherapy in food allergic children \< 30 months of age. The main question it aims to answer is: What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction. Participants will receive oral immunotherapy for 1 year with a maintenance dose of 300 mg allergenic protein and are compared with food allergic infants not receiving oral immunotherapy to compare with natural tolerance development.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-02-11; most recent amendment 2025-09-15.
Trial Details
NCT Number NCT05738798
Lead Sponsor Deventer Ziekenhuis
Collaborators: Dutch National Health Care Institute, University of Twente, Utrecht University
Conditions Food Allergy
Enrollment 500 participants
Start Date 2023-02-01
Primary Completion 2026-08-30 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-16