Effects of GOS/PDX Supplemented Formula in Preventing and Modifying the History of Allergy and Acute Infections in a Population of Infants at Risk of Atopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Cumulative incidence
研究概览
简要总结
The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that prebiotics reduce the severity of the disease.
详细描述
This study is a prospective, double blind, randomised, 24 month study trial comparing formula with 50/50 mixture of GOS/PDX (Enfamil Premium Infant Formula 1 for children <6 months and Formula 2 for children ≥ 6 months) versus standard formula (Enfamil Premium Formula 1 and 2).
Study population is composed by newborns at risk for allergy that will be identified at time of delivery. Infants will be eligible if at least one parent or one older sibling have a physician-diagnosed atopic disease (asthma, allergic rhinoconjunctivitis , atopic dermatitis, allergic urticaria, and food allergy as follow described. At time of enrolment (within the first 4 weeks of life) infants will be randomised 1:1 to receive once they will start formula feeding before the day of the 6th month birthday.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 1 Week 至 24 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age >37 and < 42 weeks.
- •Birth weight > 2500 gr.
- •At risk of atopy (see appendix 1).
- •Informed consent signed by the parents (see appendix 3).
排除标准
- •Congenital immunodeficiency
- •Severe congenital disorders or malformations
- •Born to mother with diabet
- •Long term intake (> 7 consecutive days) of pro- or prebiotics
- •Children who have already assumed ≥ 50 mL for feeding bottle of Formulas different from the one object of this study for up to a month.
- •Parents expected not to be compliant with the study procedures
结局指标
主要结局
Cumulative incidence
时间窗: 36 - 48 weeks
Cumulative incidence of atopic dermatitis at 36 and 48 weeks
次要结局
- Severity(36-48 weeks)
研究者
Alfredo Guarino
Head physician of Department of Translational Medical Science
Federico II University