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

NCT07040111 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-07-01

No results posted yet for this study

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

Interventions

OTHER

oral food challenge (OFC)

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)

OTHER

oral food challenge (OFC)

oral food challenges with subsequent steps of a 5-step egg ladder (muffin \[0.75 g of hen's egg protein per portion\], muffin \[1.5 g of hen's egg protein per portion\], pancake, hard-boiled egg, soft-boiled egg)

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Hanna Szajewska, MD, Professor · Medical University of Warsaw

  • Anna Nowak-Węgrzyn, MD, Professor · Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of Medicine

  • Andrea Horvath, MD, PhD · Medical Univeristy of Warsaw

  • Joanna Jerzyńska, MD, PhD · Medical Univeristy of Lodz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2028-07-31
Completion
2028-11-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040111 on ClinicalTrials.gov