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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 4 Months - 36 Months
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05662800
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical University of Warsaw
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marek Kulus, MD, Prof.
Principal Investigator Affiliation Medical University of Warsaw
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Poland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis, Food Allergy, Peanut Allergy, Tree Nut Allergy
Additional Details

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).

Contact a Trial Team

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International Sites

Warsaw, Masovian, Poland

Status

Recruiting

Address

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

Warsaw, Masovian, 02-091

Site Contact

Klaudia Ryczaj, MD

klaudia.ryczaj@gmail.com

+48 22 317 94 19

Bydgoszcz, Poland

Status

Recruiting

Address

Department of Pediatrics, Allergology and Gastroenterology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University

Bydgoszcz, , 85-067

Site Contact

Aneta Krogulska, MD, Prof.

marek.kulus@wum.edu.pl

+48 52 585 48 50

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