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The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Infant Formula | Active Comparator | Milk-based infant formula |
|
| Experimental Infant Formula | Experimental | Milk-based Infant Formula with oligosaccharides |
|
| Reference Group | Other | Human-milk fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Infant Formula | Other | Ready to feed infant formula, feed ad libitum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight gain per day | Day of life 14 - 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Characteristics | Parent completed diary | Study Day 1 to Day of life 119 |
| Formula Tolerance | Parent completed diary | Study Day 1 to Day of life 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Sample | Microbiota characterization | Study Day 1 to Day of life 119 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timberly Williams, PhD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watching Over Mothers & Babies | Tucson | Arizona | 85712 | United States | ||
| Pediatric Medical Associates |
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| Experimental Infant Formula |
| Other |
Ready to feed infant formula, feed ad libitum |
|
| Reference Group | Other | Human milk, breast feeding ad libitum |
|
| Length | Length gain per day | Study Day 1 to Day of life 119 |
| Head Circumference (HC) | HC gain per day | Study Day 1 to Day of life 119 |
| Illness Incidence | Parent reported incidence of illness | Study Day 1 to Day of life 119 |
| Sacramento |
| California |
| 95815 |
| United States |
| Norwich Pediatric Group, P.C. | Norwich | Connecticut | 06360 | United States |
| Phoenix Medical Research LLC | Miami | Florida | 33165 | United States |
| University Clinical Research-Deland, LLC a/b/a Accel Clinical Research | Orlando | Florida | 32829 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Deaconess Clinic, Inc. | Evansville | Indiana | 47725 | United States |
| Michael W. Simon, M.D., PSC | Nicholasville | Kentucky | 40356 | United States |
| Springs Medical Research | Owensboro | Kentucky | 42303 | United States |
| Institute of Clinical Research, LLC | Mentor | Ohio | 44060 | United States |
| The Cleveland Pediatric Research Center, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Midsouth Center for Clinical Research | Memphis | Tennessee | 38116 | United States |
| ARC Clinical Research at Wilson Parke | Austin | Texas | 78726 | United States |
| Ventavia Research Group, LLC | Fort Worth | Texas | 76104 | United States |
| Ventavia Research Group | Houston | Texas | 77008 | United States |
| Ventavia Research Group, LLC 3078 | Keller | Texas | 76248 | United States |
| Kagan Pediatrics - HD Research Corporation | Pearland | Texas | 77584 | United States |
| Plano Pediatrics - ACRC Trials | Plano | Texas | 75093 | United States |