NCT06287385已完成不适用
An Exploratory Real-world Study to Explore the Effects of a Goat-milk Based Formula on Gut Health and Related Health Benefits in Healthy, Term-born Chinese Young Children
Danone Nutricia2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2024年3月28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
- 121
- 试验地点
- 2
- 主要终点
- Stool characteristics
研究概览
简要总结
This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 1-2 years of age
- •Healthy term infants, gestational ages 37~42 weeks
- •Birth weight within normal range for gestational age and sex (10th to 90th percentile of the Chinese Child Growth Chart);
- •Normal weight, height at screening (10th to 90th percentile of the Chinese Child Growth Chart)
- •Chinese population;
- •Subjects whose parents/guardians are intending to goat formula feed according to protocol during the study period;
- •Informed consent from one parent or legal representative;
- •Subjects whose parents/guardians are adults, have sufficient ability in Chinese to complete informed consent and other study documents;
- •Subjects whose parents/guardians are able to use smart phone with cameras; install and use a secure WeChat platform on the mobile phone during the study period; connect to the network through the mobile phone; take photos to record stool; complete questionnaires;
- •Subjects whose parents/guardians can be directly contacted by telephone or WeChat throughout the study.
排除标准
- •Probiotics or probiotics-supplemented products use within 4 weeks prior to enrolment;
- •Goat-milk based formula or fresh goat milk use within 4 weeks prior to enrolment;
- •Special infant formula use within 4 weeks prior to enrolment, including but not limited to hydrolysed infant formula, lactose-free infant formula and anti-reflux infant formula etc.;
- •Known allergy to milk products or soy product;
- •Medially diagnosed disorders requiring a special diet, including but not limited to reflux esophagitis, phenylketonuria etc;
- •Significant congenital abnormality or other health conditions that could affect the outcome measurements;
- •Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements;
- •Participation in any other studies involving investigational or marketed products concomitantly or within 4 weeks prior to entry into the study.
结局指标
主要结局
Stool characteristics
时间窗: before and 7, 14, 21 and 28 days after administration of the investigational product
Stool characteristics assessed with BITSS
次要结局
- Quality of life of subjects(before and 28 days after administration of the investigational product)
- Lifestyle-related immune indicators(before and 28 days after administration of the investigational product)
- Gastrointestinal symptoms(before and 7, 14, 21 and 28 days after administration of the investigational product)
研究者
研究点 (2)
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