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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662800
• Other study ID #: RG 2/2021
• Status: Recruiting
• Start date: April 17, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2023
• Source: Medical University of Warsaw
• Contact: Marek Kulus, MD, Prof.
• Phone: +48 22 317 94 19
• Email: marek.kulus[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Nut Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity
• Tree Nut Allergy

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Poland	Department of Pediatrics, Allergology and Gastroenterology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University	Bydgoszcz
Poland	Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw	Warsaw	Masovian

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Warsaw	Nutricia Foundation, Thermo Fisher Scientific, Inc

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Erratum In: N Engl J Med. 2016 Jul 28;375(4):398. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	2 years
Primary	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