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

Launched by MEDICAL UNIVERSITY OF WARSAW · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways of introducing egg into the diets of young children who are allergic to hen’s eggs. The trial compares a 4-step egg ladder and a 5-step egg ladder, which are gradual plans that help children slowly and safely get used to eating eggs again. The goal is to see which method is more effective and safe for helping kids build tolerance to eggs over time.

Children between 1 and 5 years old who have a confirmed allergy to hen’s eggs and have been avoiding eggs for at least six months may be eligible. To join, children need to be generally healthy and have a clear diagnosis of egg allergy, confirmed by specific allergy tests or a controlled food challenge. Families will be asked to follow the assigned egg ladder plan and work closely with the study team. The study will monitor how well the children tolerate the egg introduction and watch for any allergic reactions. This research is important because it could help standardize the best way to safely reintroduce eggs to allergic children, improving their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • Use of antihistamines within 3-10 days before the challenge (depending on the drug and indication; time-limited contradiction - relative exclusion criterion).
• • Acquired tolerance to baked hen's egg proteins or advancement to a higher step of the egg ladder.
• • Use of immunosuppressive drugs or immunotherapy.