A2 GUM Post-Market Effectiveness Study

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

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

Study Overview

• Status: Completed
• Conditions: Protein Intolerance
• Intervention / Treatment: Dietary supplement: Toddler milk

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: Interventional
• Enrollment (Actual): 387
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Institute of Reproductive and Child Health, Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A2 Growing Up Milk	Dietary supplement: Toddler milk; Commercially available toddler milk
NO_INTERVENTION: Traditional non-A2 milk
ACTIVE_COMPARATOR: Other Growing Up Milk	Dietary supplement: Toddler milk; Commercially available toddler milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall digestive comfort	Toddler Gut Comfort score from parent-reported questionnaire (sub-scale range from 1 to 6, 10 sub-scales, total scores range from 10-60).	Baseline to Study Day 14

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2018
• Primary Completion (ACTUAL): February 28, 2019
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Nutrition; Toddlers; A2; B-casein; Gut comfort; Growing up milk
• Other Study ID Numbers: 18.14.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No