NCT00792090已完成不适用
Use of Fermented Milk in Prevention of Cow's Milk Allergy in New Born and Infant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bledina
- 入组人数
- 142
- 试验地点
- 4
- 主要终点
- Sensibilisation and cow's milk allergy
研究概览
简要总结
Impact of fermented milk in prevention of cow's milk allergy in new born and infants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mother before the 5th month of pregnancy
- •mother agreeing to stop consumption of yogurts and fermented milks during the 3rd quarter of pregnancy
- •mother agreeing to receive a calcium supplementation during the 3rd quarter of pregnancy
- •atopic mother or father and at least another atopic member (sister or brother)
- •parents having given written informed consent
- •adhesion to eviction regimen for mother and child
- •parents agreeing with a regular follow-up (3 visits and monthly phone call with the dietician)
排除标准
- •mother in an exclusion period from another study
- •parents refusing to sign the informed consent
- •infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator
- •known or suspected immunodeficiency in the family
结局指标
主要结局
Sensibilisation and cow's milk allergy
时间窗: 4, 12 and 24 months
次要结局
- Sensitization or allergy to other allergens(4, 12 and 24 months)
- Atopic diseases (atopic dermatitis, asthma)(4, 12 and 24 months)
研究者
研究点 (4)
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