NCT00808756已完成不适用
Study on Fermentable Carbohydrates in Healthy Infants
University Rovira i Virgili4 个研究点 分布在 1 个国家目标入组 388 人开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 4
- 主要终点
- Children well-being and appropriate growth
研究概览
简要总结
The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.
详细描述
Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born in Reus and Tarragona area
- •Normal feeding behaviour
排除标准
- •Serious respiratory, neurological, gastrointestinal or metabolic disorders
- •Infections or other serious diseases that could interfere in normal feeding or growth
- •Parents or guardians cannot be expected to comply with protocol
- •Parents or guardians have not command on Catalan or Spanish language
结局指标
主要结局
Children well-being and appropriate growth
时间窗: up to 4 months
次要结局
- Secondary outcomes will be metabolic parameters.(Up to 4 months)
研究者
Ricardo Closa-Monasterolo
Ricardo Closa Monasterolo, MD, PhD
University Rovira i Virgili
研究点 (4)
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