Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants.
详细描述
Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.
New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.
The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.
The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.
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
- — 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants of both sexes born to natural or cesarean delivery
- •Gestational age between 37 and 42 completed weeks
- •Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
- •Single birth
- •Caucasian parents
- •Infants being exclusively formula-fed by the 21st day of life
排除标准
- •Infants with genetic and/or congenital diseases
- •Infants receiving antibiotic therapy
- •Infants with neonatal diseases requiring hospitalisation for longer than 7 days
- •Infants at risk for atopy and/or having familial history for atopy
- •Mothers with metabolic or chronic diseases
- •Infant selected for another clinical study
- •Parents refusing to sign a written informed consent
结局指标
主要结局
The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms
时间窗: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.
Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.
次要结局
- Immune-modulatory activity(At enrolment, after 60 and 135 days of life)
- Prebiotic effect(At enrolment and after 135 days of life)