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| Name | Class |
|---|---|
| Shenzhen University | OTHER |
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Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Formula 1 | Experimental |
| |
| Investigational Formula 2 | Experimental |
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| Control: Commercial Infant Formula or Dairy Products | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Formula 1 | Dietary Supplement | The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Height | Measured in centimeters (cm) | Baseline (Day -7) to Day 90 |
| Change in Weight | Measured in kilograms (kg) | Baseline (Day -7) to Day 90 |
| Comprehensive Nutritional Development Assessment | (1) Annual growth rate (cm/year); (2) MUAC to head circumference ratio; (3) Weight-for-age Z-score (WAZ); (4) Length-for-age Z-score (LAZ); (5) Weight-for-length Z-score (WLZ); (6) BMI-for-age Z-score (BAZ). | Baseline (Day -7) to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Salivary sIgA | Saliva sample collected in microliters (µL) | Baseline (Day -7) to Day 90 |
| Change in Salivary Lysozyme | Saliva sample collected in microliters (µL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pantian Huang | Contact | +86 13430375474 | umi.huang@hh.global | |
| Siwan Peng | Contact | +86 13543117452 | pengsiwan@zhunter.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen University | Recruiting | Shenzhen | Guangdong | 518060 | China |
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| Investigational Formula 2 | Dietary Supplement | The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals |
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| Baseline (Day -7) to Day 90 |
| Change in Fecal sIgA | Stool sample collected | Baseline (Day -7) to Day 90 |
| Change in Fecal Calprotectin | Stool sample collected | Baseline (Day -7) to Day 90 |
| Change in Fecal Alpha-1 Antitrypsin (AAT) | Stool sample collected | Baseline (Day -7) to Day 90 |
| Change in Gut Microbiome Composition (Metagenomics) | Stool sample collected for metagenomic sequencing | Baseline (Day -7) to Day 90 |
| Change in Fecal Metabolome (Non-targeted Metabolomics) | Stool sample collected for metabolomic analysis | Baseline (Day -7) to Day 90 |
| Change in IGSQ Score | Questionnaire administered by site staff | Baseline (Day -7) to Day 90 |
| Change in Stool Consistency (Brussels Infant Stool Hardness Scale) | Questionnaire administered by site staff | Baseline (Day -7) to Day 90 |
| Change in TSAS Score | Questionnaire administered by site staff | Baseline (Day -7) to Day 90 |