Randomized, Parallel, Double-blind Study With a Partially Hydrolyzed Infant Formula With Cow's Milk Protein vs a Formula With Intact Protein to Assess Growth and Impact on the Gastrointestinal Manifestations of Colic in the Healthy Infant.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- Growth standard calculated z-scores
研究概览
简要总结
Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic
详细描述
Demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children diagnosed as nursing colic according to Roma IV criteria.
- •Infants who have received breastfeeding at least 2 weeks.
- •Infants who at the time of inclusion in the study whose parents/legal guardians voluntarily decide not to continue exclusive breastfeeding or only maintain it in residual form (less than 20% of the daily intake, one breast intake per day).
- •Full-term infants (>37 weeks of gestation).
- •Infants with weight suitable for their gestational age (2500-4500g).
- •Normal APGAR score: 7-
- •Infants between 2 and 8 weeks of life.
- •Infants whose parents/legal guardians have signed informed consent.
- •Infants with good availability of clinical follow-up until the end of the study.
排除标准
- •Infants fed from birth with exclusive infant formula.
- •Infants with congenital diseases or malformations that may affect growth.
- •Infants with major medical conditions that require chronic medication or close medical checks.
- •Infants who have taken any type of antibiotics or probiotics prior to the study.
结局指标
主要结局
Growth standard calculated z-scores
时间窗: From baseline to 3 months after starting with the formula
Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)
Symptoms associated with infant colic
时间窗: From baseline to 3 months after starting with the formula
Hours of crying, wakefulness, sleep for 24 hours, by adapting Barr's crying letter
次要结局
- Product safety(At 1, 2 and 3 months follow-up visit, and 6, 9 months old)
- Growth standard calculated z-scores(At 6, 9 and 12 months old.)
- Assessment of supplementary food(At 6 and 9 months old)
- Infant illness and infection outcomes(Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old)
- Behaviour/temperament test(1, 6, 12 months old)
- Gatrointestinal tolerance recording(Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old)
- Food survey at the first year of life(At 12 months old)