Evaluation of the Effect of a New Infant Formula With Specific Ingredients on the Development of the Immune System and the Gastrointestinal Health of the Infant
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Register of diarrhea episodes
研究概览
简要总结
The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.
详细描述
Nowadays, almost all commercial infant formulas resemble the "gold standard" of breast milk in terms of composition of essential nutrients, but it is still a challenge to identify and incorporate certain bioactive components capable of replicating those stimuli typical of breast milk that can program growth, infant development and maturation of the immune system.
The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.
In addition, considering that the quality of feeding at these early ages will program (Early programming) the health and physiology of the child and the future adult, the study wants to obtain evidence of the effects of this new infant formula on the immune system and the development of the child compared to breast milk during the first year of life, hoping that it promotes proper growth, adequate cognitive development and maturation of the immune system as similar as possible to children fed to the mother's breast.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion age from 0 to 2.5 months of age.
- •Gestational age >37 weeks and <41 weeks inclusive.
- •Appropriate birth weight appropriate for your gestational age (between 10-90 percentiles).
- •APGAR score normal birth to 1' and 5' of 7 -
- •Umbilical pH ≥ 7.
- •Availability to continue throughout the study period.
- •Written informed consent
- •Additional Inclusion Criteria for groups 1 and 2:
- •Infants who, at the time of recruitment, have already passed the diet with a majority or exclusive formula for medical reasons, by decision of the parents or any other reason agreed with the pediatrician.
- •Additional Inclusion Criteria for group 3 (breastfeed infants):
- •Infants who have been breastfed until the second month with exclusive or majority breastfeeding.
- •Infants who are expected to be exclusively or predominantly breastfed up to 6 months.
排除标准
- •Simultaneous participation in other clinical trials.
- •Infants suffering from gastrointestinal disorders (allergy and/or intolerance to cow's milk protein or lactose).
- •Mother's pathology history and during gestation: neurological diseases, metabolic disorders, type 1 diabetes mellitus, chronic disease (hypothyroidism), maternal malnutrition, TORCH syndrome.
- •Treatment of the mother's anxiolytics or antidepressants. Other treatments with drugs potentially harmful to neurodevelopment.
- •Inability of the parents to follow up the study (medical decision).
结局指标
主要结局
Register of diarrhea episodes
时间窗: From baseline to 12 months.
Presence and duration of diarrhea, registered in patients dairies.
Register of fever episodes
时间窗: From baseline to 12 months.
Presence and duration of the fever and treatments, through diaries completed by parents
Register of infections
时间窗: From baseline to 12 months
Register of infant infections through patient diaries completed by parents
次要结局
- Obstetric background(Baseline)
- Study of the infant microbiota(At 3, 6 and 12 months.)
- Immune response evaluation(At 3, 6 and 12 months of age)
- Demographic data(From baseline to 12 months.)
- Infant neurodevelopment(At 12 months)
- Infant neurodevelopment 2(At 2, 3, 4, 6, 9 and 12 months of age.)
- Assessment of normal growth of the infant(From baseline to 12 months.)
- Infant neurodevelopment 3(At 2, 3 and 4 months of life.)
- Infant neurodevelopment 5(12 months of age)
- Infant neurodevelopment 4(6 and 12 months of age)