NCT01184378已完成2 期
Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lactalis
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- digestibility of lipids in formula
研究概览
简要总结
The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.
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 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal growth;
- •considered as healthy by the investigator according to the medical interrogation and the clinical examination;
- •receiving exclusively infant formula for at least 15 days.
- •without any solid food during the month of the study
排除标准
- •Premature born children or small born weights;
- •Children breast-fed or weaned for less than 15 days;
- •Children with solid food
- •Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
- •Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
- •Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
- •Children under medical treatment (ex: paracetamol).
结局指标
主要结局
digestibility of lipids in formula
时间窗: during the 30d consumption period
lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake
次要结局
- tolerance and growth(during the 30d of formula intake)
研究者
研究点 (4)
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