NCT03204630已完成不适用
Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk
Biosearch S.A.4 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2011年1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
- 236
- 试验地点
- 4
- 主要终点
- Body weight gain
研究概览
简要总结
A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Weeks 至 5 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
- •Signature of informed parental or guardian consent.
排除标准
- •Allergic to the protein in cow's milk.
- •Lactose intolerant.
- •Suffering from a serious metabolic disease.
- •They have experienced or are experiencing some severe gastrointestinal disease.
- •Receive some form of chronic medication or are receiving antibiotics at the time of capture.
- •Low expectation of compliance with the study protocol.
- •allergic to any group of antibiotics.
结局指标
主要结局
Body weight gain
时间窗: 12 months versus baseline
Body weight gain at 12 months (grams)
次要结局
- Length(1,2,4,6,9 and 12 months of age)
- Body weight(1,2,4,6,9 and 12 months of age)
- Incidence of infections(total incidence during intervention (11 months))
- Bacterial load in feces(1,2,4,6,9 and 12 months of age)
- Regurgitation(each 2 weeks until 6 months of age and monthly until 12 months of age)
- Fecal deposition(each 2 weeks until 6 months of age and monthly until 12 months of age)
- Infant colic(each 2 weeks until 6 months of age and monthly until 12 months of age)
- Flatulency(each 2 weeks until 6 months of age and monthly until 12 months of age)
- Hours of night sleep(each 2 weeks until 6 months of age and monthly until 12 months of age)
- Total hours of sleep/day(each 2 weeks until 6 months of age and monthly until 12 months of age)
研究者
研究点 (4)
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