Clinical trial NCT05662800: Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy
Official title: Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Food Allergy
Peanut Allergy
Tree Nut Allergy
Keywords: atopic dermatitis
peanuts
tree nuts
sesame
food allergy
children
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
name: Thermo Fisher Scientific, Inc
First posted: 2022-12-23
Enrollment: 240
Sex: ALL
Minimum age (years): 4
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The children will be recruited using mailing to general paediatric, allergy, and dermatology practices and directly to two allergy centers (Warsaw and Bydgoszcz).

Brief summary: 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: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The prevalence of peanut, tree nut and sesame allergy in Polish children with high risk of food allergy
timeFrame: 1-2 days
Secondary outcomes:
Other outcomes:
measure: The timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population
timeFrame: 2 years
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
state: Masovian
city: Bydgoszcz
country: Poland
facility: Department of Pediatrics, Allergology and Gastroenterology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University
Study officials:
affiliation: Medical University of Warsaw
name: Marek Kulus, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.
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