A2 GUM Post-Market Effectiveness Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 4, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

September 15, 2018

Estimated Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Toddler Gut Comfort score from parent-reported questionnaire

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^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

Descriptive Information

Brief Title ^ICMJE

A2 GUM Post-Market Effectiveness Study

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Dietary Supplement: Toddler milk
Commercially available toddler milk

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

360

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2018

Estimated Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

12 Months and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Nestlé

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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