An observational study in Atopic Dermatitis, Food Allergy and Peanut Allergy, sponsored by Medical University of Warsaw. Status unknown at 2 sites in Poland. Open to participants aged 4 Months to 36 Months. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Medical University of Warsaw · Observational
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.
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).
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 240 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
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The children will be recruited using mailing to general paediatric, allergy, and dermatology practices and directly to two allergy centers (Warsaw and Bydgoszcz).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Assessment of eczema severity: Eczema severity will be assessed based on the objective SCORing Atopic Dermatitis (SCORAD), use of topical , 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 1-2 days
The timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population
Assessment of the prevalence of peanuts, tree nuts and sesame allergy (based on data related to allergen consumption, SPT, sIgE and OFC; as described in Outcome 1) will be performed in the investigated group with ensured equal representation of age. The study will aim to recruit 20% of children aged 4 to 6 months, 15% aged 7 to 9 months, 15% aged 10 to 12 months, 15% aged 13 to 18 months, 15% aged 19 to 24 months and 20% in the third year of life.
Time frame: 2 years
Plan to share: Yes — The datasets used and/or generated during this study will be made available after the publication of results, no later than 3 years from the completion of data analysis.
Supporting information: Clinical study report
Time frame: Up to 3 years after completion of data analysis.
Access criteria: The datasets will be made available from the contact author upon reasonable request.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw →