Institute of Reproductive and Child Health, Peking University
Beijing, China
NCT Number: NCT03698058
This is a post-market, real-life effectiveness study of A2 growing up milk on toddlers' gut comfort.
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Notify Me12 month–36 month
All sexes
Interventional
Not applicable
Beijing, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Commercially available toddler milk
Time frame: Baseline to Study Day 14
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, Study Day 7, Study Day 14
Stool frequency reported by parents in 3-Day GI Symptoms Diary
Time frame: Baseline, Study Day 7, Study Day 14
Stool consistency score reported by parents in 3-Day GI Symptoms Diary
Time frame: Baseline, Study Day 7, Study Day 14
Reported by parents on 3 consecutive days on Milk Intake Diary
Time frame: Baseline, Study Day 7, Study Day 14
Weight as measured by study staff in health clinic
Time frame: Baseline, Study Day 7, Study Day 14
Weight as measured by study staff in health clinic
Time frame: Baseline, Study Day 7, Study Day 14
Head circumference as measured by study staff in health clinic
Time frame: Baseline to Study Day 14
All adverse events reported by parents and confirmed by study investigator
Société des Produits Nestlé (SPN)
Industry
Real-World Effectiveness Study of A2 Growing Up Milk (GUM) Among Young and Pre-School Age Toddlers in China
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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