跳至主要内容
临床试验/NCT01584245
NCT01584245终止不适用

Evaluation of the Efficacy of an Amino Acid Based Formula in Infants

Mead Johnson Nutrition6 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
32
试验地点
6
主要终点
Weight gain

研究概览

简要总结

This clinical trial will evaluate the efficacy of an amino acid formula in infants with allergic manifestations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group

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

  • Weight loss within the past 4 weeks
  • Infants 1-12 months of age feeding a hypoallergenic formula for at least 2 weeks
  • Birth weight greater than or equal to 1500 grams
  • Solely enteral fed
  • Infants with at least one persistent allergy symptom
  • No change in medication within 10 days of beginning the study and no plans for change during the first 10 days of the study
  • Signed informed consent

排除标准

  • History of underlying condition which, in the Investigator's opinion, could interfere with normal growth, development, or assessment of the participant
  • Metabolic disease requiring special attention

结局指标

主要结局

Weight gain

时间窗: 12 weeks

次要结局

  • Allergic manifestations(12 weeks)

研究者

发起方
Mead Johnson Nutrition
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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