Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
oral food challenge (OFC)
Other interventionoral 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)
oral food challenge (OFC)
Other interventionoral 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)
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: 4-Step Egg LadderExperimental treatment 1 intervention
Group B: 5-Step Egg LadderActive comparator 1 intervention
Trial outcomes
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.
Time frame
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
1
The percentage of children with a negative OFC at each step of the EL protocol upon completion of the study's observation period
Calculated as the proportion of children tolerating the full planned dose for each step.
Time frame
18 weeks and 24 weeks, depending on the study arm2
The percentage of children who experienced anaphylaxis
The proportion of children who experience anaphylaxis defined as reactions with severity grades 3-5 according to the updated 2023 WAO clinical criteria for anaphylaxis.
Time frame
During the observation period (18 or 24 weeks, depending on study arm),3
The proportion of children with anaphylaxis (grades 3-5, per 2023 WAO criteria) who required epinephrine administration.
The proportion of children who experienced anaphylaxis and required epinephrine will be reported in three categories: * those who require one or two doses of intramuscular epinephrine with a good clinical response (less severe reaction, grade 3), * those who require more than 2 doses of intramuscular epinephrine, * those with lack of significant clinical improvement after two doses (severe reactions, grades 4-5).
Time frame
Measured during the observation period (18 or 24 weeks, depending on the study arm).4
The proportion of children who experienced systemic allergic reactions (SAR) of grades 1, 2, and 3 according to the 2023 WAO grading system.
The proportion of children who experienced SAR will be reported in three categories: * grade 1: includes nausea and/or mild abdominal pain without altered activity; * grade 2: persisting (≥20 mins) and non-distractable abdominal pain and/or vomiting (not due to gag or taste aversion) and/or diarrhea; * grade 3: severe, persistent (≥20 minutes), intractable abdominal pain and/or vomiting (excluding retching or taste aversion) and/or diarrhea, assessed during each OFC.
Time frame
Measured during the observation period (18 or 24 weeks, depending on the study arm).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: