NCT02077088已完成不适用
Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants
Humana Co.Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
研究概览
简要总结
Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family
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
- 年龄范围
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nonbreastfed eutrophic infants of corresponding gestational age
- •presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma)
排除标准
- •children with serious disease,
- •breastfed children
- •children fed another formula then the ones used
研究组 & 干预措施
Galactooligosaccharides
Experimental
addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula
干预措施: galactooligosaccharide (Other)
Only HA formula
No Intervention
only standard HA starter formula
结局指标
主要结局
SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
时间窗: at 6 months of age
objective evaluation of atopic symptoms
次要结局
- anthropometric parameters (height, weight)(at 6 months of age)
研究者
研究点 (1)
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