NL-OMON39465已完成3 期
A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis. - SAINT
Danone Research - Centre for Specialised Nutrition0 个研究点目标入组 144 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
入选标准
- •- Infants/children with atopic dermatitis
- •- up to and includig 10 months of age
- •- Expected daily intake of at least 500ml of the study product
排除标准
- •- Intolerance for any other component of the study product(s)
- •- History of anaphylactic reaction to cow*s milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction.
- •- Use of antihistamines prior to (48 hours) the study.
- •- Use of oral steroids prior to (4 weeks) the study.
- •- Use of antibiotics or antimycotic drugs prior to (4 weeks) the study.
- •- History or presence of cardiovascular, gastrointestinal, hepatic, renal or respiratory chronic disease other than allergy.
- •- Major congenital abnormalities.
- •- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
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