Oral Immunotherapy in Young Children With Food Allergy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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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

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Food Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized open trial (no placebo involved)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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oral immunotherapy

oral immunotherapy, maintenance phase with daily 300 mg allergenic protein during 1 year

Group Type EXPERIMENTAL

oral immunotherapy

Intervention Type DIETARY_SUPPLEMENT

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.

routine care

strictly avoidance of the specific allergenic food

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No