NCT03698058已完成不适用
Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 387 人开始时间: 2018年9月15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
- 387
- 试验地点
- 1
- 主要终点
- Overall digestive comfort
研究概览
简要总结
This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.
详细描述
This post-market study primarily aims to assess the real-life effectiveness of a newly-launched A2 milk on toddlers' gut comfort via evaluating individual GI symptoms and GI-related behaviors compared with other milk products and milk alternatives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.
- •Children 12 - 36 months of age at enrolment.
- •Children who have been born full-term (≥ 37 completed weeks of gestation) and having a birth weight ≥ 2.5 kg and ≤ 4.5 kg.
- •Children who are habitually consuming some cow's milk, other traditional milks (including non-A2 GUMs, kids' milk, white milk, flavored milk) and/or dairy or non-dairy alternative milks (such as those sourced from goats, sheep, soy, rice, coconut, and nut).
- •Child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study protocol.
排除标准
- •Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact outcome measures.
- •Known and diagnosed cow's milk protein allergy.
- •Children currently using or having ever used specialty infant formula and/or GUMs such as hypoallergenic (HA), lactose-free, or anti-regurgitation formulas.
- •Children who have known cognitive and developmental disorders.
结局指标
主要结局
Overall digestive comfort
时间窗: Baseline to Study Day 14
Toddler Gut Comfort score from parent-reported questionnaire (sub-scale range from 1 to 6, 10 sub-scales, total scores range from 10-60).
次要结局
- Adverse events(Baseline to Study Day 14)
- Stool frequency(Baseline, Study Day 7, Study Day 14)
- Stool consistency(Baseline, Study Day 7, Study Day 14)
- Consumption of other milk products(Baseline, Study Day 7, Study Day 14)
- Child weight(Baseline, Study Day 7, Study Day 14)
- Child height(Baseline, Study Day 7, Study Day 14)
- Child head circumference(Baseline, Study Day 7, Study Day 14)
研究者
研究点 (1)
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