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NOT YET RECRUITING
NCT07040111
NA

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

Sponsor: Medical University of Warsaw

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

1 Year - 5 Years

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2025-07

Completion Date

2028-11

Last Updated

2025-07-01

Healthy Volunteers

No

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)

Locations (2)

Medical Univeristy of Warsaw, Department of Paediatrics

Warsaw, Poland

Medical Univeristy of Warsaw

Warsaw, Poland