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The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational infant formula A | Experimental | Investigational Protein Hydrolysate formula |
|
| Hydrolysate based Infant Formula | Active Comparator |
| |
| Investigational Infant Formula B | Experimental | Investigational Protein Hydrolysate Formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolysate based infant formula | Other | Infant formula ad lib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| GI tolerance via stool consistency | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
• An adverse maternal, fetal or infant medical history and treatment with antibiotics
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| Name | Affiliation | Role |
|---|---|---|
| Marlene Borschel, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | United States | ||
| Alabama Clinical Therapeutics, LLC |
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| Investigational Infant Formula A |
| Other |
Investigational infant formula ad lib |
|
| Investigational Infant Formula B | Other | Investigational infant formula ad lib |
|
| Dothan |
| Alabama |
| 36305 |
| United States |
| SCORE Physician Alliance | St. Petersburg | Florida | 33710 | United States |
| University of Iowa | Coralville | Iowa | 52241 | United States |
| Medical Associates Clinic, PC | Dubuque | Iowa | 52001 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Ohio Pediatric Research Association | Huber Heights | Ohio | 45424 | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | 44124 | United States |
| Pediatric Clinical Research Office | Hershey | Pennsylvania | 17033 | United States |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | United States |