Tolerance of Healthy Term Infants Fed Infant Formulas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 15
- 主要终点
- Gastrointestinal tolerance
研究概览
简要总结
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
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
- — 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age
排除标准
- •medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth
研究组 & 干预措施
1
Experimental milk protein based infant formula with varying carbohydrate and protein source
干预措施: milk protein formulas, varying carbohydrate/protein sources (Other)
2
Experimental milk protein based infant formula with varying carbohydrate and protein source
干预措施: milk protein formulas, varying carbohydrate/protein sources (Other)
3
Experimental milk protein based infant formula with varying carbohydrate and protein source
干预措施: milk protein formulas, varying carbohydrate/protein sources (Other)
4
Experimental milk protein based infant formula with varying carbohydrate and protein source
干预措施: milk protein formulas, varying carbohydrate/protein sources (Other)
5
Experimental milk protein based infant formula with varying carbohydrate and protein source
干预措施: milk protein formulas, varying carbohydrate/protein sources (Other)
结局指标
主要结局
Gastrointestinal tolerance
时间窗: 0-8 days of age until 28 days of age
次要结局
- GI and intake parameters(0-8 to 28 days of age)