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This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Infant Formula | Active Comparator | Ready-to-Feed (RTF) Soy Infant Formula |
|
| Experimental Infant Formula 1 | Experimental | Experimental Ready-to-Feed Soy Formula |
|
| Experimental Infant Formula 2 | Experimental | Experimental Ready-to-Feed Soy Formula |
|
| Experimental Infant Formula 3 | Experimental | Experimental Ready-to-Feed Soy Formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Infant Formula 1 | Other | method A phytate reduction and 5% protein hydrolysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool Characteristics Questionnaire | stool number, consistency, and color | Change from Baseline (Study Day 1) to Study Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Formula Intake | volume consumed | Change from Baseline (Study Day 1) to Study Day 15 |
| Gastrointestinal Tolerance Questionnaire | Incidence of spit up and vomiting |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lasekan, MBA, PhD, CCRP | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Dreyer Clinic |
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| Experimental Infant Formula 2 | Other | method A phytate reduction and 10% protein hydrolysis |
|
| Experimental Infant Formula 3 | Other | method B phytate reduction and 5% protein hydrolysis |
|
| Active Comparator: Control Infant Formula | Other | Ready-to-Feed (RTF) Soy Infant Formula |
|
| Change from Baseline (Study Day 1) to Study Day 15 |
| Weight | weight and weight gain | Change from Baseline (Study Day 1) to Study Day 15 |
| Aurora |
| Illinois |
| 60506 |
| United States |
| T&W Research | Owensboro | Kentucky | 42302 | United States |
| Park Nicollet Medical Foundation | Minneapolis | Minnesota | 55416 | United States |
| Clinical Studies, Inc | Canton | Ohio | 44709 | United States |
| Research Memphis | Memphis | Tennessee | 38119 | United States |
| Child Care Associates | San Antonio | Texas | 78212 | United States |