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The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Soy formula | Experimental | experimental soy formula #1 |
|
| 2: Soy Formula | Active Comparator | Commercially available soy formula |
|
| 3: Soy formula | Experimental | experimental soy formula #2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy protein formula | Other | ad lib for 0-35 days of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age. | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age | 35 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lasekan, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Institute | Little Rock | Arkansas | 72202 | United States | ||
| All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc |
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| Commercially available soy formula | Other | ad lib for 0-35 days of age |
|
| Soy formula experimental #2 | Other | ad lib for 0-35 days of age |
|
|
| Plantation |
| Florida |
| 33324 |
| United States |
| SCORE Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| University of South Florida Health Pediatrics | Tampa | Florida | 33606 | United States |
| North Georgia Clinical Research | Dalton | Georgia | 30721 | United States |
| Medical Associates Clinic | Dubuque | Iowa | 52002 | United States |
| Kentucky Pediatric Research | Bardstown | Kentucky | 40004 | United States |
| PediaResearch, LLC | Owensboro | Kentucky | 42301 | United States |
| Midwest Children's Health Research Institute, LLC | Lincoln | Nebraska | 68504 | United States |
| Center for Human Nutrition | Omaha | Nebraska | 68105 | United States |
| Pediatric Associates of Mount Carmel, Inc | Cincinnati | Ohio | 45245 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Dayton Clinical Research | Dayton | Ohio | 45406 | United States |
| Ohio Pediatric Research Association | Huber Heights | Ohio | 45424 | United States |
| Institute of Clinical Research, LLC | Mayfield Heights | Ohio | 44124 | United States |
| Primary Physician's Research, Inc | Pittsburgh | Pennsylvania | 15241 | United States |
| West Virginia University, Department of Pediatrics | Morgantown | West Virginia | 26506 | United States |