NCT03925558已完成不适用
Tolerance of a Probiotic Formula Containing Lactobacilli
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 36
- 主要终点
- Head circumference (cm)
研究概览
简要总结
Evaluate the tolerance of a probiotic formula in infants
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 Days 至 95 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full term healthy infant aged 3-95 days
排除标准
- •Prematurity
- •Low birth weight
- •Congenital anomalies
- •Chronic disease
- •Failure to thrive
- •Allergy or atopic disease
- •Recent exposure to antibiotics
研究组 & 干预措施
Probiotic formula
Active Comparator
Lactobacillus strains
干预措施: Probiotics (Dietary Supplement)
Placebo formula
Placebo Comparator
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Head circumference (cm)
时间窗: 8 weeks
Body weight (g)
时间窗: 8 weeks
Body length (cm)
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
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