Assessment of Growth of Infants Fed Starter Formulas With Modified Protein and Synbiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 试验地点
- 6
- 主要终点
- Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)
研究概览
简要总结
The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.
详细描述
Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.
The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Days 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn infant
- •Full-term (> 37 weeks gestation)
- •Birth weight > 2500 and < 4500 g
- •14±3 days of age on enrollment
- •Singleton birth
- •Infant's mother has elected not to breastfeed prior to enrollment
- •Has not received solid foods
- •Having obtained his/her legal representative's informed consent
排除标准
- •Known or suspected cow-milk allergy
- •Congenital illness or malformation that may affect infant feeding and/or growth
- •Significant prenatal and/or postnatal disease
- •Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
- •Receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- •Has received oral or intravenous antibiotic therapy in the last 7 days
- •Has received probiotics in the last 7 days
- •Currently participating in another clinical study
- •Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen)
结局指标
主要结局
Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months)
时间窗: 4 months
次要结局
- Tolerance, morbidity, protein status, metabolic markers(6 months)