An interventional study of oral food challenge (OFC) and oral food challenge (OFC) in Food Allergy, Egg Allergy and Hen Egg Allergy, sponsored by Medical University of Warsaw. Not yet recruiting at 2 sites in Poland. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment
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.
Introducing baked egg into the diet of children with hen's egg allergy has been shown to potentially accelerate the development of tolerance to raw egg. However, there is no standardised egg ladder protocol, and different scientific societies across countries recommend varying versions.
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-ML) in children with IgE-mediated hen's egg allergy.
An open-label randomised trial with two parallel arms in two departments of the same academic hospital will be performed. A total of 84 children with IgE-mediated hen's egg allergy will be allocated to introduce hen's egg into their diet according to either 4-EL or 5-EL with a 6-week break period between subsequent steps. Oral food challenge (OFCs) with tested products at each subsequent step of the egg ladder will be conducted in hospital settings. 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. Soft-boiled egg will be administered at the end of the observation period (18 or 24 weeks, depending on the assigned study arm). 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.
Secondary outcomes will include the percentage of children with a negative OFC to each egg ladder step; the percentage of children with anaphylaxis (both those who were treated and who were not treated with adrenaline); the percentage of children with exacerbation of atopic dermatitis; growth; compliance; and quality of life of the caregivers and parents' anxiety about adverse events during their child's OFC.
The statistical analyses will be conducted with StatsDirect. The Mann-Whitney U test will be used to compare the means of continuous variables if non-normal distribution will be assessed. Proportions will be compared with the Fisher exact test. The difference in study groups was considered significant when the P value will be \<05. The results of this study will be analyzed on the basis of intention to treat.
38 studies on the registry are indexed under Egg Hypersensitivity; 9 are open to participants now.
This study's planned enrollment of 94 is above the median of 73 across 27 interventional studies indexed under Egg Hypersensitivity.
Browse Egg Hypersensitivity studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
Compared within Egg Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: oral food challenge (OFC)
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)
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)
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).
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 arm
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),
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).
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).
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.
The maximum score on the oSCORAD scale is 83 points (in the most severe cases, an additional 10 points can be added for changes that disfigure or limit the patient's functioning), the minimum score is 0 points; the more points, the greater intensity of changes. Any documented exacerbation of atopic dermatitis symptoms following OFC will be also recorded.
Time frame: Upon completion of the observation period (18 or 24 weeks, depending on the assigned study arm).
Change in age-adjusted z-scores for weight and length/height, evaluated using the WHO growth charts.
Time frame: During the observation period (18 or 24 weeks, depending on study arm).
Change in the total score of the FAQLQ-PF.
The questionnaire is divided into three domains: emotional impact, food anxiety, and social and dietary limitations. The total score is calculated as the mean of three subscales. The minimum score is 0, the maximum score is 6. The lower the score, the more life affecting the allergy is.
Time frame: At the end of the observation period (18 weeks and 24 weeks, depending on the study arm) from baseline.
Mean difference in caregiver anxiety levels, measured by the Subjective Units of Distress Scale (SUDS)
parents will rate their level of anxiety on a scale from 1 to 100, where 0 represents no anxiety or complete relaxation, and 100 represents extreme anxiety, the worst ever experienced.
Time frame: Prior to each OFC, between study groups at each time point (18-24 weeks, depending on the study arm).
The proportion of children with full adherence to the intervention protocol.
The proportion of children with full adherence to the intervention protocol, defined as consumption of at least one portion of a tolerated hen's egg proteins dose three times during last week of break in period, in the same form and quantity as tested during the OFC. Data will be collected through the Egg Ladder Monitoring Diary and assessed throughout each break in period (between the following steps of each ladder).
Time frame: at the end of the observation period (18 or 24 weeks, depending on the assigned study arm)
Plan to share: Yes — The results of this RCT, whether positive or negative, will be published in a peer-reviewed journal (data will be submitted to the first journal after 3-6 months from study completion). Abstracts will also be submitted to relevant national and international conferences. The datasets used and/or generated during this study will be made available from a given author upon reasonable request, after the publication of results, no later than 3 years from the completion of data analysis.
Supporting information: 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.
Start is estimated for Jul 2025; primary completion for Jul 2028, 36 months later.
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw →