Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy

NCT07040111 | Not Yet Recruiting DMC

• 1 other identifier: HE2025
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

Hen's Egg Allergy is one of the most common food allergies in early childhood. The first-line treatment is the elimination of hen's egg proteins from the child's or maternal diet. Available data from the literature indicate that most children with hen's egg allergy acquire tolerance to hen's egg proteins with age. An assessment of tolerance acquisition to them is commonly performed using egg ladder. However, scientific evidence regarding the effectiveness and safety of the egg ladder in children with hen's egg allergy is limited. Currently, there is no standardised egg ladder protocol, and different versions of the ladder and recommend by scientific societies in various countries. This study aims to assess the effectiveness and safety of the 4-step egg ladder (4-EL) compared to the 5-step egg ladder (5-EL) in children with IgE-mediated hen's egg allergy. This is an open-label, randomised superiority trial with two parallel arms and a 1:1 allocation ratio.

Conditions

Food Allergy; Egg Allergy; Hen Egg Allergy

Keywords

children; egg ladder; IgE-mediated hen egg allergy

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the percentage of children who acquire tolerance to soft-boiled hen's egg (almost raw hen's egg proteins)

  The primary outcome is the percentage of children who acquire tolerance to soft-boiled hen's egg (almost raw hen's egg proteins), as determined by a negative OFC at the final step of the EL. The challenge dose will consist of 0.5-1 egg for children aged 1-3 years and 1 egg for those aged 4-5 years, corresponding to a maximum total of 6 g of hen's egg proteins.

  Soft-boiled egg will be administered at the end of the observation period (18 or 24 weeks, depending on the assigned study arm).

Secondary Outcomes (9)

• The percentage of children with a negative OFC at each step of the EL protocol upon completion of the study's observation period

  18 weeks and 24 weeks, depending on the study arm

• The percentage of children who experienced anaphylaxis

  During the observation period (18 or 24 weeks, depending on study arm),

• The proportion of children with anaphylaxis (grades 3-5, per 2023 WAO criteria) who required epinephrine administration.

  Measured during the observation period (18 or 24 weeks, depending on the study arm).

• The proportion of children who experienced systemic allergic reactions (SAR) of grades 1, 2, and 3 according to the 2023 WAO grading system.

  Measured during the observation period (18 or 24 weeks, depending on the study arm).

• In the subgroup of children with atopic dermatitis, changes in the total score of the oSCORAD index will be assessed. before and after each OFC.

  Upon completion of the observation period (18 or 24 weeks, depending on the assigned study arm).

Study Arms (2)

4-Step Egg Ladder

EXPERIMENTAL

Other: oral food challenge (OFC)

5-Step Egg Ladder

ACTIVE COMPARATOR

Other: oral food challenge (OFC)

Interventions

oral food challenge (OFC) OTHER

oral food challenges with subsequent steps of a 4-step egg ladder (muffin \[1.5 g of hen's egg protein per portion\], pancake, hard-boiled egg, soft-boiled egg)

4-Step Egg Ladder

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 12 months and ≤ 5 years.
• Diagnosis of IgE-mediated HEA confirmed according to the EAACI guidelines by a positive OFC with hen's egg proteins. In children with high-risk HEA (e.g., history of anaphylaxis), diagnosis can be based on elevated specific IgE levels (3.5 kU/l) to hen's egg proteins and/or individual egg components and/or positive skin tests.
• On a therapeutic elimination diet for at least 6 months, measured from the last allergic reaction to egg (in accordance with BSACI guidelines).
• Eligible regardless of the risk of systemic reactions (e.g. anaphylaxis) or asthma.
• Good general health.
• Written informed consent signed by the child's guardians.
• Demonstrated good cooperation from the patient's guardians.

You may not qualify if:

• Confirmed wheat allergy and/or celiac disease.
• Uncontrolled asthma, defined as the presence of shortness of breath, cough, chest tightness, or auscultatory changes despite treatment.
• Signs of exacerbation of a chronic disease.
• Signs of acute infectious disease (e.g. acute rhinitis, cough, subfebrile or febrile states).
• Signs of exacerbation of another allergic disease (e.g., conjunctivitis, allergic rhinitis, atopic dermatitis).
• Anaphylaxis due to hen's egg proteins within the last 6 months.
• Acquired tolerance to baked hen's egg proteins or advancement to a higher step of the egg ladder.
• Use of immunosuppressive drugs or immunotherapy.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (2)

Medical Univeristy of Warsaw, Department of Paediatrics

Warsaw, Poland

Location

Medical Univeristy of Warsaw

Warsaw, Poland

Location

Related Publications (1)

• Horvath A, Bujnowska A, Strozyk A, Zemla M, Nowak-Wegrzyn A, Grzela K, Jerzynska J, Szajewska H. Efficacy and safety of a 4-step versus a 5-step egg ladder in children with IgE-mediated hen's egg protein allergy: protocol for an open-label randomized controlled trial. Front Allergy. 2025 Sep 15;6:1658186. doi: 10.3389/falgy.2025.1658186. eCollection 2025.

  PMID: 41031391 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hanna Szajewska, MD, Professor

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Anna Nowak-Węgrzyn, MD, Professor

  Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of Medicine

  PRINCIPAL INVESTIGATOR

• Andrea Horvath, MD, PhD

  Medical Univeristy of Warsaw

  PRINCIPAL INVESTIGATOR

• Joanna Jerzyńska, MD, PhD

  Medical Univeristy of Lodz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Horvath, MD, PhD

CONTACT

048 22 317 94 44; andrea.horvath@wum.edu.pl

Maria Zemla, MD

CONTACT

048 602 850 070; maria.zemla@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the publication of results, no later than 3 years from the completion of data analysis with no end date.
• Access Criteria: Upon reasonable request.

Locations

PL (2)