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

NCT ID: NCT05662800

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2025-04-30

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).

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia Foundation

OTHER

Sponsor Role: collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marek Kulus, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw

Warsaw, Masovian Voivodeship, Poland

Site Status: RECRUITING

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

Bydgoszcz, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Marek Kulus, MD, Prof.

Role: CONTACT

marek.kulus@wum.edu.pl

+48 22 317 94 19

Klaudia Ryczaj, MD

Role: CONTACT

klaudia.ryczaj@gmail.com

+48 22 317 94 19

Facility Contacts

Klaudia Ryczaj, MD

Role: primary

klaudia.ryczaj@gmail.com

+48 22 317 94 19

Aneta Krogulska, MD, Prof.

Role: primary

+48 52 585 48 50

Julia Gawryjołek, MD, PhD

Role: backup

gawryjolek.j@gmail.com

+48 52 585 48 50

References

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.

Reference Type: BACKGROUND

PMID: 31866098 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25705822 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26943128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19000582 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28065278 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37973545 (View on PubMed)

Other Identifiers

RG 2/2021

Identifier Type: -

Identifier Source: org_study_id