A2 GUM Post-Market Effectiveness Study

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

Detailed Description
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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.

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

Conditions
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Protein Intolerance

Intervention / Treatment
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* Dietary Supplement: Toddler milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A2 Growing Up Milk<br> | Dietary Supplement: Toddler milk<br>* Commercially available toddler milk<br>|
| No Intervention: Traditional non-A2 milk<br> | |
| Active Comparator: Other Growing Up Milk<br> | Dietary Supplement: Toddler milk<br>* Commercially available toddler milk<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Toddlers, A2, B-casein, Gut comfort, Growing up milk