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临床试验/NCT02144428
NCT02144428Unknown不适用

DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY

Federico II University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年4月最近更新:
适应症

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

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

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Berni Canani

MD, PhD

Federico II University

研究点 (1)

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