This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
387
Commercially available toddler milk
Institute of Reproductive and Child Health, Peking University
Beijing, China
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).
Time frame: Baseline to Study Day 14
Stool frequency
Stool frequency reported by parents in 3-Day GI Symptoms Diary
Time frame: Baseline, Study Day 7, Study Day 14
Stool consistency
Stool consistency score reported by parents in 3-Day GI Symptoms Diary
Time frame: Baseline, Study Day 7, Study Day 14
Consumption of other milk products
Reported by parents on 3 consecutive days on Milk Intake Diary
Time frame: Baseline, Study Day 7, Study Day 14
Child weight
Weight as measured by study staff in health clinic
Time frame: Baseline, Study Day 7, Study Day 14
Child height
Weight as measured by study staff in health clinic
Time frame: Baseline, Study Day 7, Study Day 14
Child head circumference
Head circumference as measured by study staff in health clinic
Time frame: Baseline, Study Day 7, Study Day 14
Adverse events
All adverse events reported by parents and confirmed by study investigator
Time frame: Baseline to Study Day 14
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