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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A2 Growing Up Milk | Experimental |
| |
| Traditional non-A2 milk | No Intervention | ||
| Other Growing Up Milk | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toddler milk | Dietary Supplement | Commercially available toddler milk |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Reproductive and Child Health, Peking University | Beijing | China |
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| 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 |