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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- The primary outcome is the percentage of children who acquire tolerance to soft-boiled hen's egg (almost raw hen's egg proteins)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
The primary outcome is the percentage of children who acquire tolerance to soft-boiled hen's egg (almost raw hen's egg proteins)
时间窗: 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.
次要结局
- The percentage of children with a negative OFC at each step of the EL protocol upon completion of the study's observation period(18 weeks and 24 weeks, depending on the study arm)
- The percentage of children who experienced anaphylaxis(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.(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.(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.(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.(During the observation period (18 or 24 weeks, depending on study arm).)
- Change in the total score of the FAQLQ-PF.(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)(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.(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(18 weeks and 24 weeks, depending on the study arm)
- The percentage of children who experienced anaphylaxis(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.(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.(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.(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.(During the observation period (18 or 24 weeks, depending on study arm).)
- Change in the total score of the FAQLQ-PF.(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)(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.(at the end of the observation period (18 or 24 weeks, depending on the assigned study arm))
研究者
Andrea Horvath-Stolarczyk
Associate Professor
Medical University of Warsaw