Dietary Choice for the Management of Cow's Milk Allergy Influences the Acquisition of Oral Tolerance and the Occurrence of Other Allergic Manifestations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Rate of subjects with occurrence of other of allergic manifestations
研究概览
简要总结
Food allergy is a common chronic condition in childhood. Recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. The increased food allergy prevalence in children has an important economic impact, with significant direct costs for the healthcare system and even larger costs for the families of food-allergic patients. In addition, children with food allergies are at increased risk to develop other allergic manifestations later in life. According to a recent study, children with a food allergy are 2 to 4 times more likely to develop other atopic manifestations such as asthma (4.0 times), atopic eczema (2.4 times), and respiratory allergies (3.6 times), compared to children without a food allergy. Cow's milk allergy is among the most common food allergy in early childhood, with an estimated prevalence of 2% to 3%. It has been previously showed that in children with cow milk allergy, an extensively hydrolysed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG induced higher tolerance rates compared to extensively hydrolysed casein formula without Lactobacillus rhamnosus GG and other formulas. These findings were consistent with those of a 1-year follow-up study performed in the US that showed better outcomes using an extensively hydrolysed casein formula+Lactobacillus rhamnosus GG vs. an extensively hydrolysed casein formula or amino acid-based formula for the first-line dietary management of cow milk allergy. In addition it has been recently demonstrated that extensively hydrolysed casein formula + Lactobacillus rhamnosus GG reduces the incidence of other atopic manifestations and hastens the development of oral tolerance in children with IgE-mediated cow milk allergy.
The present randomized controlled trial (RCT) was designed to test whether different dietary interventions could influence the occurrence of other atopic manifestations in children with IgE-mediated cow milk allergy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 1-12 months
- •IgE-mediated CMA
排除标准
- •cow's milk protein-induced anaphylaxis,
- •food protein induced enterocolitis syndrome,
- •other food allergies,
- •other allergic diseases,
- •non-CMA-related atopic eczema,
- •eosinophilic disorders of the gastrointestinal tract,
- •chronic systemic diseases,
- •congenital cardiac defects,
- •active tuberculosis,
- •autoimmune diseases,
- •immunodeficiency,
- •chronic inflammatory bowel diseases,
- •celiac disease,
- •cystic fibrosis,
- •metabolic diseases,
- •malignancy,
- •chronic pulmonary diseases,
- •malformations of the gastrointestinal and/or respiratory tract,
- •administration of prebiotics or probiotics during the 4 weeks before enrolment.
结局指标
主要结局
Rate of subjects with occurrence of other of allergic manifestations
时间窗: 3 years
To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy
次要结局
- Change in metagenomics and metabolomics(3 years)
- Rate of subjects with tolerance acquisition to cow's milk(after 4 to 6 years follow-up)
- Rate of subjects with any autoimmune disease(6 years)
- Rate of subjects with occurrence of other of allergic manifestations(after 4 to 6 years follow-up)
- Epigenetic modifications in cytokines genes(3 years)
研究者
Roberto Berni Canani, MD, PhD
Associate Professor
Federico II University