Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 14
- 主要终点
- The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.
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 a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.
详细描述
Oligosaccharides are one of the major breast milk components. They are not digested and reach the colon where they're used by selected groups of microflora positive bacteria, specifically bifidobacteria and lactobacilli.
Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants.
Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants.
However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.
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
- 1 Day 至 15 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy infants of both sexes, born at term with natural labor or cesarean birth
- •Single birth
- •Infant born between 37th - 42th gestation week (included)
- •Infant with birth weight ≥ 2500 g
- •APGAR score after 5 minutes of life > 7
- •Infant born from parents of Caucasian race
- •Exclusive breast feeding or formula feeding within 15 days from birth.
- •Consensus form signed by both parents or by the legal tutor properly informed of the study.
- •Parents able to understand the protocol requirements and to fill out the infants Diary.
排除标准
- •Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
- •Diseases jeopardizing intrauterine growth.
- •Infant born from mother suffering from dismetabolic and/or chronic diseases.
- •Unknown father
- •Infant with parents who might not report at hospital controls or not follow the protocol.
- •Infant already enrolled or selected for another clinical trial.
结局指标
主要结局
The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.
时间窗: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.
次要结局
- The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples.(Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life.)