Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy

Study Overview
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Brief Summary
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The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.

Detailed Description
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Introduction: Peanut allergy (PA) has become a health concern world-wide for several decades. Sesame allergy, although less prevalent, is also causing growing concern. Peanut, tree nuts, and sesame allergy co-exist in 60% of children. Although the majority of PA cases come from the general population, there are well-established risk factors for this allergy, such as eczema and egg allergy. In the Learning Early About Peanut (LEAP) Study, early introduction of peanut into the diet of children with moderate-to-severe eczema or egg allergy was proven to be effective in PA prevention. This strategy has now been adopted by national allergy societies in the USA and Australia as part of the weaning guidance for the high-risk populations.However, it is not known whether early introduction of peanut is also justified in other populations where peanut consumption has traditionally been lower. Getting insight into the prevalence of nut and sesame allergy in the cohort of infants and toddlers in Central Europe is needed to guide early dietary intervention strategies. Methods: 240 children with eczema or egg allergy will undertake extensive assessment of peanut, tree nuts (hazelnut, almond, cashew, pistachio, walnut, macadamia) and sesame allergy status through consumption history, skin testing, specific immunoglobulin E measurement (sIgE) and oral food challenges (OFCs).

Official Title
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Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy

Conditions
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Atopic Dermatitis, Food Allergy, Peanut Allergy, Tree Nut Allergy

Intervention / Treatment
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* Diagnostic Test: Assessment of peanut, tree nuts and sesame allergy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate or severe eczema and/or egg allergy, at least one complementary food already introduced, signed informed consent. Assessment of eczema severity: Eczema severity will be assessed based on the objective SCORing Atopic Dermatitis (SCORAD), use of topical steroids, calcineurin inhibitors or systemic treatment as well as history of hospital admission. Definition of egg allergy: Participants with a documented IgE-mediated egg allergy will be identified by a convincing history of a reaction in the presence of a positive skin prick test (SPT) (wheal diameter of 3 mm or greater with egg white extract) or an SPT ≥ 5mm with no history of a reaction. Exclusion Criteria: inability to withdraw antihistamines for at least 5 days prior to testing, use of prohibited medication such as beta-blockers, angiotensin-converting-enzyme inhibitors (ACE-I) and biological treatments affecting the immunological response, uncontrolled asthma or eczema which does not warrant readiness for a food challenge within the study time frame, chronic urticaria, chronic systemic diseases.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Assessment of peanut, tree nuts and sesame allergy|Children will undergo skin prick testing with the following allergens: commercial extracts for peanut, hazelnut, almond, cashew, pistachio, walnut, macadamia, sesame, Timothy grass, and birch pollen; positive and negative control; peanut butter and tahini (sesame) paste. Specific IgE levels will be quantified to all the above-listed tree nuts, peanuts, sesame seed and peanut components (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, Ara h 9). Children will undertake cumulative or incremental oral food challenge with peanut, sesame and tree nuts, depending on the risk assessment based on patient's medical history and results of diagnostic tests.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of peanut, tree nut and sesame allergy in Polish children with high risk of food allergy | Based on data related to allergen consumption, SPT, and OFC, patients will be classified as allergic to peanuts and sesame or non-allergic. Based on the results of SPT, sIgE, and OFCs are performed in exceptional situations, patients will be classified as allergic, non-allergic, or likely not allergic to selected tree nuts. | 1-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, peanuts, tree nuts, sesame, food allergy, children