Oral Immunotherapy in Young Children With Food Allergy

Last updated: August 12, 2024
Sponsor: Deventer Ziekenhuis
Overall Status: Active - Enrolling

Phase

N/A

Condition

Allergy

Allergy (Pediatric)

Allergies & Asthma

Treatment

oral immunotherapy

Clinical Study ID

NCT05738798
NL81774.075.22
  • Ages 9-30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An IgE-mediated food allergy to peanut, cashew, hazelnut, walnut, cow's milk and/orhen's egg as proven by sensitization to the specific allergen (sIgE > 0.35kU/l) anda positive oral food challenge.

  • The fore-mentioned allergens are introduced into the diet of the child (the child istolerant for the specific allergen(s)), or the child is diagnosed with a foodallergy for the specific allergen(s).

Exclusion

Exclusion Criteria:

  • (Suspected) eosinophilic oesophagitis

  • Uncontrolled asthma/ viral wheeze.

  • The inability of parents to follow instructions, recognize allergic reactions oradminister emergency medication.

  • Participation in any other intervention study at the time of the OIT study, with theexception of studies on guided early introduction of highly allergenic foods.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: oral immunotherapy
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
May 01, 2026

Study 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.

Connect with a study center

  • Deventer hospital

    Deventer, Overijssel 7416SE
    Netherlands

    Site Not Available

  • Amsterdam UMC, location AMC

    Amsterdam,
    Netherlands

    Site Not Available

  • Reinier de Graaf Gasthuis

    Delft,
    Netherlands

    Site Not Available

  • Martini hospital

    Groningen,
    Netherlands

    Site Not Available

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