跳至主要内容
临床试验/NCT01073033
NCT01073033已完成不适用

Oral Supplement for Pregnant and Lactating Mothers to Promote Infant Immune Maturation and Protection Against Early Life Infections

Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2010年4月1日最近更新:
适应症

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

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)

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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