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临床试验/NCT01634490
NCT01634490已完成不适用

Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy

Federico II University0 个研究点目标入组 300 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
主要终点
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy

研究概览

简要总结

Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.

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

入选标准

  • Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated

排除标准

  • Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.

结局指标

主要结局

the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy

时间窗: about 4 year

. Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.

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

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