Oral Supplement for Pregnant and Lactating Mothers to Promote Infant Immune Maturation and Protection Against Early Life Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- The incidence of diarrhea in infants from birth to 1 year
研究概览
简要总结
To assess protection against early life infections through supplementation of mothers during pregnancy to the newborns' growth, morbidity, immune status intra and extra-uterine.
详细描述
During pregnancy mothers have to fulfill the tremendous physiological needs to support their own immune status as well as that of their babies. Accordingly, it appears highly valuable to provide mothers with a nutritional supplement during pregnancy and lactation to promote the immune development in newborns, thus reinforcing the infants' defenses.
In that respect, an appropriate maternal diet must provide sufficient energy and nutrients to meet the mother's usual requirements and promote health status, as well as the needs of the growing fetus and beyond for the neonate.
Key organogenesis steps take place during fetal life and many functional features of the immune system are already coded in the genetic asset of the individual. However, at birth the immune system remains fairly immature. An epigenetic, postnatal instruction seems to be extremely important for the maturation of the immune system allowing its full functionality.
The cross-talk between the mother and her baby is, indeed, crucial for the optimal development of the foetus and subsequently for the full and functional maturation of the neonate.
The newborn relies for his protection almost exclusively on his innate immune system that is initially instructed and educated early in life by factors derived from his mother as well as post-natal environmental factors such as early life colonization with micro-organisms that activates the innate immunity and enhance Th1-cell polarization thereby potentially reducing atopic dermatitis with respect to the hygiene hypothesis.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Expecting mothers who are in their 6th month of pregnancy
- •Willing to consume 2 x 200 ml of test product daily
- •Willing to exclusively breastfeed until the baby is at least 2-month old
- •Having signed the informed consent
排除标准
- •Known allergy to cow's milk
- •Subjects previously diagnosed HIV(+) and Hepatitis B (+)
- •Multiple pregnancy
- •High risk pregnancy (pre-eclampsia, diabetes, etc)
- •Currently participating or having participated in another clinical trial during the last 3 months
- •Subjects who consumed pro- and /or prebiotics-containing food/supplement* in the month before inclusion
结局指标
主要结局
The incidence of diarrhea in infants from birth to 1 year
时间窗: 24 months
次要结局
- In mothers: fetal growth, general health, immune system, metabolomics profile and preterm delivery(18 months)
- In infants: growth, morbidity, immune maturation, metabolomics profile(18 months)
