Oral Immunotherapy in Young Children With Food Allergy (ORKA-NL)

Deventer Ziekenhuis

Status

Invitation-only

Conditions

Food Allergy

Treatments

Dietary Supplement: oral immunotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05738798

NL81774.075.22

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

9 to 30 months old

Volunteers

No Healthy Volunteers

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.