Tolerance to Baked Goods in Children Under 5 Years Allergic to Cow's Milk or Egg Proteins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- 1. To evaluate proportion of children who develop tolerance to raw milk or cooked/raw egg at 12 months.
研究概览
简要总结
Food allergies are more common in children, especially in Western countries. Around 5 to 8% of children have at least one food allergy, compared to only 1-2% of adults. These allergies can really affect child's quality of life and create stress for the whole family. The most common foods that cause allergic reactions are cow's milk, egg, nuts, fish, and shellfish.
Until now, the usual way to manage a food allergy has been to completely avoid the food. But this can be hard, limiting kids diets and puts them at risk of accidental exposure, and may even cause nutritional problems.
Oral immunotherapy (OIT) has become and alternative treatment. It consists in giving very small amounts of the food allergen regularly to help the body get used to it. Some studies show this helps children build tolerance faster than just avoiding the food. But OIT also comes with risks, including allergic reactions during the treatment, some of which can be serious.
Some research is focusing on a gentler and safer option: giving children baked milk or baked egg. When milk or egg is baked (for example, in muffins or cookies), the high heat changes the proteins, making them less likely to cause allergic reactions. The heat breaks the parts of the protein that the immune system usually reacts to, and mixing them with wheat flour makes them even less reactive.
Interestingly, this doesn't work for every food, peanuts, for example, can actually become more allergenic when heated. But in the case of milk and egg, baking seems to be very helpful.
Giving baked milk or egg to allergic children has shown some immune system changes similar to OIT, but in a safer and more natural way. This can make life a lot easier, not just for the kids, but also for their families since it broadens their diet, improves their nutrition, and reduces stress in social situations.
Studies suggest that introducing baked milk and egg early on could also help kids become fully tolerant sooner.
At Sant Joan de Déu Hospital in Barcelona, doctors have been using OIT for milk and egg allergies since 2006 in children over 5 years old. While the treatment has helped many, not all children become fully desensitized, and some still react to milk or egg occasionally. The success rate is around 70%, and it's often less effective in children with severe allergies, like those who have had anaphylaxis.
详细描述
This is a 12-month, prospective, randomized interventional study designed to evaluate immunological tolerance development in young children with confirmed cow's milk or egg allergy. The primary endpoint is the acquisition of clinical tolerance to raw or minimally processed forms of the allergen after structured dietary exposure to baked forms. The study integrates immunologic, clinical, and laboratory evaluations to assess the therapeutic potential and immunomodulatory effects of gradual allergen introduction.
Study Population Inclusion Criteria Age: 12 to 72 months (1 to 6 years). Milk Allergy Subgroup: Confirmed diagnosis based on at least one of the following: suggestive clinical history, positive skin prick test (SPT) ≥3 mm over negative control and/or specific IgE ≥0.35 kU/L to cow's milk or casein.
Egg Allergy Subgroup: Either: suggestive clinical history and sensitization (SPT or sIgE ≥0.35 kU/L to egg white or ovomucoid).
Exclusion Criteria Inability to obtain written informed consent. Any contraindication to epinephrine use (e.g., uncorrected congenital heart disease).
Ongoing consumption of baked milk or egg ≥3 times/week within the last 3 months.
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
- 12 Months 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with confirmed allergy to cow's milk or cooked egg
排除标准
- •Contraindication to epinephrine use
- •Ongoing consumption of baked milk or egg goods
结局指标
主要结局
1. To evaluate proportion of children who develop tolerance to raw milk or cooked/raw egg at 12 months.
时间窗: 12 months from enrollment
Proportion of participants who achieve clinical tolerance to raw cow's milk or cooked/raw egg following 12 months of intervention. All participants underwent a controlled oral food challenge (OFC) in day's hospital. The intervention will be evaluated positively if the participant become tolerant. An increase in the reaction threshold dose relative to the initial OFC will also be considered favorable. If symptoms appear immediately, the patient will be considered allergic.
次要结局
- Change in immunologic markers (IgE, IgG4, Tregs, BAT).(12 months intervention)
- Rate of reactions during oral food challenges.(12 months intervention)
- Changes in threshold dose triggering reactions.(12 months intervention)
