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Recruitment challenges
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| Name | Class |
|---|---|
| Beijing Kangchen Technologies | UNKNOWN |
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The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Cow milk-based infant formula | Active Comparator | Cow milk-based infant formula |
|
| Experimental 1: Cow milk-based infant formula | Experimental | Cow milk-based infant formula with prebiotics |
|
| Experimental 2: Cow milk-based infant formula | Experimental | Cow milk-based infant formula with probiotics |
|
| Experimental 3: Cow milk-based infant formula | Experimental | Cow milk-based infant formula with prebiotics and probiotics |
|
| Human Milk Reference | No Intervention | Human Milk Reference |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control: Cow milk-based infant formula | Other |
| ||
| Experimental 1: Cow milk-based infant formula |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal microbiota | 3.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight measured at each study visit | Up to 3.5 months | |
| Body Length measured at each study visit | Up to 3.5 months | |
| Head circumference measured at each study visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Wu | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Province Women & Children Hospital | Haikou | Hainan | China |
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| Other |
Experimental 1: Cow milk-based infant formula with prebiotics |
|
| Experimental 2: Cow milk-based infant formula | Other | Experimental 2: Cow milk-based infant formula with probiotics |
|
| Experimental 3: Cow milk-based infant formula | Other | Experimental 3: Cow milk-based infant formula with prebiotics and probiotics |
|
| Up to 3.5 months |
| Recall of infant formula usage at each study visit | Up to 3.5 months |
| Recall of gastrointestinal tolerance questionnaire at each study visit | Up to 3.5 months |
| Medically-confirmed adverse events collected throughout the study period | Up to 3.5 months |