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

NCT05662800 | Unknown DMC

• 1 other identifier: RG 2/2021
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis; Food Allergy; Peanut Allergy; Tree Nut Allergy

Keywords

atopic dermatitis; peanuts; tree nuts; sesame; food allergy; children

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• The timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population

  2 years

Interventions

Assessment of peanut, tree nuts and sesame allergy DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 4 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Nutricia Foundation: collaborator
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (2)

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

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

Bydgoszcz, 85-067, Poland

RECRUITING

Related Publications (6)

• 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.

  PMID: 31866098 BACKGROUND

• Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23.

  PMID: 25705822 BACKGROUND

• Perkin MR, Logan K, Tseng A, Raji B, Ayis S, Peacock J, Brough H, Marrs T, Radulovic S, Craven J, Flohr C, Lack G; EAT Study Team. Randomized Trial of Introduction of Allergenic Foods in Breast-Fed Infants. N Engl J Med. 2016 May 5;374(18):1733-43. doi: 10.1056/NEJMoa1514210. Epub 2016 Mar 4.

  PMID: 26943128 BACKGROUND

• Du Toit G, Katz Y, Sasieni P, Mesher D, Maleki SJ, Fisher HR, Fox AT, Turcanu V, Amir T, Zadik-Mnuhin G, Cohen A, Livne I, Lack G. Early consumption of peanuts in infancy is associated with a low prevalence of peanut allergy. J Allergy Clin Immunol. 2008 Nov;122(5):984-91. doi: 10.1016/j.jaci.2008.08.039.

  PMID: 19000582 BACKGROUND

• Togias A, Cooper SF, Acebal ML, Assa'ad A, Baker JR Jr, Beck LA, Block J, Byrd-Bredbenner C, Chan ES, Eichenfield LF, Fleischer DM, Fuchs GJ 3rd, Furuta GT, Greenhawt MJ, Gupta RS, Habich M, Jones SM, Keaton K, Muraro A, Plaut M, Rosenwasser LJ, Rotrosen D, Sampson HA, Schneider LC, Sicherer SH, Sidbury R, Spergel J, Stukus DR, Venter C, Boyce JA. Addendum guidelines for the prevention of peanut allergy in the United States: Report of the National Institute of Allergy and Infectious Diseases-sponsored expert panel. J Allergy Clin Immunol. 2017 Jan;139(1):29-44. doi: 10.1016/j.jaci.2016.10.010.

  PMID: 28065278 BACKGROUND

• Ryczaj K, Szczukocka-Zych A, Wawszczak M, Gawryjolek J, Krogulska A, Krawiec M, Horvath A, Szajewska H, Santos A, Bahnson HT, Kulus M. Development of peanut, sesame and tree nut allergy in Polish children at high risk of food allergy: a protocol for a cross-sectional study. BMJ Open. 2023 Nov 16;13(11):e074168. doi: 10.1136/bmjopen-2023-074168.

  PMID: 37973545 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Dermatitis, Atopic; Food Hypersensitivity; Peanut Hypersensitivity; Nut Hypersensitivity; SeSAME syndrome

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Study Officials

• Marek Kulus, MD, Prof.

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Kulus, MD, Prof.

CONTACT

+48 22 317 94 19; marek.kulus@wum.edu.pl

Klaudia Ryczaj, MD

CONTACT

+48 22 317 94 19; klaudia.ryczaj@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 23, 2022
• Study Start: April 17, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.

Locations

PL (2)