A2 GUM Post-Market Effectiveness Study

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追踪信息

首次提交日期 ^ICMJE

October 4, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

September 15, 2018

预计主要完成日期

December 31, 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Overall digestive comfort[ Time Frame: Baseline to Study Day 14 ]

Toddler Gut Comfort score from parent-reported questionnaire

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Stool frequency[ Time Frame: Baseline, Study Day 7, Study Day 14 ]
Stool frequency reported by parents in 3-Day GI Symptoms Diary
Stool consistency[ Time Frame: Baseline, Study Day 7, Study Day 14 ]
Stool consistency score reported by parents in 3-Day GI Symptoms Diary
Consumption of other milk products[ Time Frame: Baseline, Study Day 7, Study Day 14 ]
Reported by parents on 3 consecutive days on Milk Intake Diary
Child weight[ Time Frame: Baseline, Study Day 7, Study Day 14 ]
Weight as measured by study staff in health clinic
Child height[ Time Frame: Baseline, Study Day 7, Study Day 14 ]
Weight as measured by study staff in health clinic
Child head circumference[ Time Frame: Baseline, Study Day 7, Study Day 14 ]
Head circumference as measured by study staff in health clinic
Adverse events[ Time Frame: Baseline to Study Day 14 ]
All adverse events reported by parents and confirmed by study investigator

描述性信息

简略标题 ^ICMJE

A2 GUM Post-Market Effectiveness Study

正式标题 ^ICMJE

Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China

简要概况

This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Prevention

适用条件 ^ICMJE

干预项目 ^ICMJE

Dietary Supplement: Toddler milk
Commercially available toddler milk

研究工具

Experimental: A2 Growing Up Milk
No Intervention: Traditional non-A2 milk
Active Comparator: Other Growing Up Milk

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

360

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2018

预计主要完成日期

December 31, 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

性别

参与研究的性别:

All

年龄

最小年龄：12 Months ，最大年龄：36 Months

接受健康的志愿者

没有

可入组国家 ^ICMJE

China

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Nestlé

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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