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

April 18, 2023 updated by: Medical University of Warsaw
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-067
        • Recruiting
        • Department of Pediatrics, Allergology and Gastroenterology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University
        • Contact:
          • Aneta Krogulska, MD, Prof.
          • Phone Number: +48 52 585 48 50
        • Contact:
    • Masovian
      • Warsaw, Masovian, Poland, 02-091
        • Recruiting
        • Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 months (Child)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of peanut, tree nut and sesame allergy in Polish children with high risk of food allergy
Time Frame: 1-2 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Nutricia Foundation
Thermo Fisher Scientific, Inc

Investigators

  • Principal Investigator: Marek Kulus, MD, Prof., Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2023

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG 2/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Up to 3 years after completion of data analysis.

IPD Sharing Access Criteria

The datasets will be made available from the contact author upon reasonable request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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