Food AllergyNCT07040111
Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy
A study testing oral food challenge (OFC) in people with Food Allergy and Egg Allergy, run by Medical University of Warsaw at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Food Allergy, Egg Allergy, Hen Egg Allergy
- What is being tested?
- oral food challenge (OFC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesPoland
- Study dates
- Jul 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites
Medical Univeristy of Warsaw, Department of Paediatrics
Warsaw
Maria Zemla, 602 850 070, maria.zemla@wum.edu.pl
Medical Univeristy of Warsaw
Warsaw
Andrea Horvath, MD PhD, 22 317 94 44, andrea.horvath@wum.edu.pl
About this study
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
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.
Read the detailed description
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.
- Conditions
- Food Allergy, Egg Allergy, Hen Egg Allergy
- Being tested
- oral food challenge (OFC)
- Keywords
- children, egg ladder, IgE-mediated hen egg allergy
- Medical subject headings
- Food Hypersensitivity, Egg Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral food challenge (OFC)Other
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 challenge (OFC)Other
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)
| Study group | Role | What they receive |
|---|---|---|
| 4-Step Egg Ladder | Experimental | Not described Receives: Other: oral food challenge (OFC) |
| 5-Step Egg Ladder | Active comparator | Not described Receives: Other: oral food challenge (OFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (9)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: at the end of the observation period (18 or 24 weeks, depending on the assigned study arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Horvath-Stolarczyk, Medical University of Warsaw
- Investigators
- Hanna Szajewska, MD, Professor, Principal investigator, Medical University of WarsawAnna Nowak-Węgrzyn, MD, Professor, Principal investigator, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of MedicineAndrea Horvath, MD, PhD, Principal investigator, Medical Univeristy of WarsawJoanna Jerzyńska, MD, PhD, Principal investigator, Medical Univeristy of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040111
- Sponsor's protocol ID
- HE2025
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Horvath A, Bujnowska A, Strozyk A, Zemla M, Nowak-Wegrzyn A, Grzela K, Jerzynska J, Szajewska H. 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. Front Allergy. 2025 Sep 15;6:1658186. doi: 10.3389/falgy.2025.1658186. eCollection 2025.
PubMed 41031391
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07040111
- Acronym / sponsor ID
- HE2025
- Conditions
- Food Allergy, Egg Allergy, Hen Egg Allergy
- Keywords
- children, egg ladder, IgE-mediated hen egg allergy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-Step Egg Ladder | Experimental | Other: oral food challenge (OFC) |
| 5-Step Egg Ladder | Active comparator | Other: oral food challenge (OFC) |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 4-Step Egg Ladder |
| 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) | Other | 5-Step Egg Ladder |
Primary outcome
The primary outcome is the percentage of children who acquire tolerance to soft-boiled hen's egg (almost raw 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 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.
9 secondary outcomes
The percentage of children with a negative OFC at each step of the EL protocol upon completion of the study's observation period
Time frame: 18 weeks and 24 weeks, depending on the study arm
The percentage of children who experienced 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.
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.
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.
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.
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)
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.
Time frame: at the end of the observation period (18 or 24 weeks, depending on the assigned study arm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Derived from this study: PubMed 41031391Horvath A, Bujnowska A, Strozyk A, Zemla M, Nowak-Wegrzyn A, Grzela K, Jerzynska J, Szajewska H. 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. Front Allergy. 2025 Sep 15;6:1658186. doi: 10.3389/falgy.2025.1658186. eCollection 2025.
- Individual participant dataSharing planned: 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.
Related trials for Food Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Not yet recruitingObservational study
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Hypersensitivity, Food, Legumes Allergy
Not yet recruiting
Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures.
Allergy, Food Allergies
Recruiting
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna Szajewska, MD, Professor principal investigator
Medical University of Warsaw
Anna Nowak-Węgrzyn, MD, Professor principal investigator
Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland; New York Univeristy, Grossmann School of Medicine
Andrea Horvath, MD, PhD principal investigator
Medical Univeristy of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral food challenge (OFC) in people with Food Allergy and Egg Allergy, run by Medical University of Warsaw at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Horvath, MD, PhD (048 22 317 94 44, andrea.horvath@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the percentage of children who acquire tolerance to soft-boiled hen's egg (almost raw 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.