NCT05738798

Oral Immunotherapy in Young Children With Food Allergy

A Randomized Controlled Trial to Investigate the (Cost)Effectiveness of Oral Immunotherapy With Different Allergens in Young Children With an Established Food Allergy

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Deventer Ziekenhuis · Academic / Other
• Sex: All
• Age: 9 Months – 30 Months
• Healthy volunteers: Not accepted

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.

Detailed description

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-mediated food allergy to peanut, tree nuts, cow's milk and/or hen's egg as proven by an oral food challenge. Intervention: 1-year low-dose oral immunotherapy (daily 300 mg allergenic protein) compared to strict avoidance in the control group. Main study parameters/endpoints: Long-term tolerance as assessed by an exit oral food challenge at 4 weeks after discontinuation of the oral immunotherapy, combined with uncomplicated consumption of a full dose of the specific food at 6 months after discontinuation of the therapy.

Conditions

• Food Allergy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral immunotherapy	oral immunotherapy is performed by freely available, widely used food products, regularly part of a normal infant's diet such as peanut butter or boiled egg.

Timeline

• Start date: 2023-02-01
• Primary completion: 2026-08-30
• Completion: 2027-05-01
• First posted: 2023-02-22
• Last updated: 2025-09-16

Locations

4 sites across 1 country: Netherlands