NCT00929292已完成3 期
Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sodilac
- 入组人数
- 66
- 试验地点
- 24
- 主要终点
- Crying duration per 24 hours
研究概览
简要总结
The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.
详细描述
This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30.
Both parents provided informed written consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy term infants with a gestational age ranging from 37 to 42 weeks
- •Non breastfed children
- •Infants with normal growth
- •Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
- •These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
- •Apgar score > 5 to 7 minutes
排除标准
- •Infants with severe regurgitations
- •Newborn currently participating in another trial
- •Infants presenting a metabolic, nervous or organic disease able to interfere with the study
- •Infants presenting lactose intolerance
- •Evidence of protein cow's milk allergy
- •Mother who wants to keep breasfeeding
结局指标
主要结局
Crying duration per 24 hours
时间窗: 1 day before the first consumption ; 3 days before days 15 and 30
次要结局
- Number of regurgitations per day(3 days before days 15 and 30)
- Gas and abdominal distensions(3 days before days 15 and 30)
- Necessary Additive treatments(3 days before days 15 and 30)
- Parents' satisfaction(Days 15 and 30)
- Agitation/Restlessness Period Duration(3 days before days 15 and 30)
- Growth Parameters(Day 30)
- Clinical Tolerance(3 days before days 15 and 30)
- Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms)(Durind the 15 first days of the diet and during the 15 last days of the diet)
研究者
研究点 (24)
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