DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of subjects with cow's milk allergy tolerant substitutive formulas
研究概览
简要总结
The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.
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
- — 至 36 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects with a cow's milk allergy
- •age between 0 to 36 months
排除标准
- •age more than 36 months
- •eosinophilic disorders of the gastrointestinal tract,
- •food protein induced enterocolitic syndrome,
- •concomitant chronic systemic diseases,
- •congenital cardiac defects,
- •active tuberculosis,
- •autoimmune diseases,
- •immunodeficiency,
- •chronic inflammatory bowel diseases,
- •celiac disease,
- •cystic fibrosis,
- •metabolic diseases,
- •lactose intolerance,
- •malignancy,
- •chronic pulmonary diseases,
- •malformations of the gastrointestinal tract.
结局指标
主要结局
Number of subjects with cow's milk allergy tolerant substitutive formulas
时间窗: At diagnosis and for at least 1 months after the diagnosis
Safety and tolerability of substitutive formulas
次要结局
未报告次要终点
研究者
Roberto Berni Canani
MD, PhD
Federico II University
