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This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Healthy infants receiving standard cow's milk-based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula | Other | Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance | Gastrointestinal tolerance is measured by stool consistency and gastrointestinal symptoms. | up to Week 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Anthropometry | Week 3, Week 6 | |
| Use of medication and nutritional supplements | Week 1, Week 3, Week 6 and Week 8 | |
| Number, type and severity of (serious) adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan van der Mooren, PhD | Danone Global Research & Innovation Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panembahan Senopati Distric Hospital | Bantul | DIY Yogyakarta | Indonesia | |||
| Sakina Idaman Mothers and Children Hospital |
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| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Week 1, Week 3, Week 6 and Week 8 |
| Yogyakarta |
| DIY Yogyakarta |
| Indonesia |
| King Chulalongkorn Memorial Hospital | Bangkok | Thailand |
| Prince of Songkhla University Hospital | Hat Yai | Thailand |
| Khon Kaen University Hospital | Khon Kaen | Thailand |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |