NL-OMON21357已完成2 期
A randomized, controlled, cross-over Study to assess Hypoallergenicity of an extensively hydrolyzed whey protein INfant formula in children with cow’s milk allErgy using amino acid-based infant formula as a reference.
utricia Research BV0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 11（—）
入选标准
- •- Children with a documented cow’s milk allergy, confirmed by one of the following criteria, within two months prior to first DBPCFC (visit 2):
- •o Positive double-blind, placebo-controlled oral food challenge (DBPCFC) with cow’s milk OR
排除标准
- •- Children who receive breastfeeding more than twice daily during the week before inclusion.
- •- Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow’s milk e.g. history of anaphylactic reaction, including severe cardiovascular symptoms, severe laryngeal edema, and bronchus obstruction.
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