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Infants will be fed infant formula and stool characteristics assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | cow-milk based infant formula |
|
| 2 | Experimental | cow milk based infant formula with prebiotics |
|
| 3 | Other | human milk reference group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal bacteria analysis | Procedure | ad lib feeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| fecal bacteria analysis | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intake, tolerance, stool characteristics, anthropometrics | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deolinda Scalabrin, MD | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Pediatric Clinic | Benton | Arkansas | 72019 | United States | ||
| Arkansas Pediatrics of Conway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26230902 | Derived | Salminen S, Endo A, Isolauri E, Scalabrin D. Early Gut Colonization With Lactobacilli and Staphylococcus in Infants: The Hygiene Hypothesis Extended. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):80-6. doi: 10.1097/MPG.0000000000000925. | |
| 21946836 | Derived | Scalabrin DM, Mitmesser SH, Welling GW, Harris CL, Marunycz JD, Walker DC, Bos NA, Tolkko S, Salminen S, Vanderhoof JA. New prebiotic blend of polydextrose and galacto-oligosaccharides has a bifidogenic effect in young infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):343-52. doi: 10.1097/MPG.0b013e318237ed95. |
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| Conway |
| Arkansas |
| 22401 |
| United States |
| The Children's Clinic of Jonesboro | Jonesboro | Arkansas | 72401 | United States |
| Altamonte Pediatric Associates | Altamonte Springs | Florida | 32701 | United States |
| Advocate Center for Pediatric Research | Park Ridge | Illinois | 60068 | United States |
| Internal Medicine and Pediatrics | Fishers | Indiana | 46038 | United States |
| East Washington Pediatrics | Indianapolis | Indiana | 46229 | United States |
| Children's Hospital of Iowa | Coralville | Iowa | 52241 | United States |
| University of Kansas Medical University | Kansas City | Kansas | 66160 | United States |
| PTCU/Children and Youth Project | Louisville | Kentucky | 40202 | United States |
| ACC Pediatric Research | Bossier City | Louisiana | 71111 | United States |
| ProMed Healthcare | Kalamazoo | Michigan | 49008 | United States |
| ProMed Pediatrics | Portage | Michigan | 49024 | United States |
| ProMed Physicians-Pediatrics | Richland | Michigan | 49083 | United States |
| The Center for Human Nutrition | Omaha | Nebraska | 68105 | United States |
| Winthrop Pediatric Associates | Mineola | New York | 11501 | United States |
| Cary Pediatric Center, P.A. | Cary | North Carolina | 27511 | United States |
| Pediatric Associates of Mt. Carmel, Inc. | Cincinnati | Ohio | 45245 | United States |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | United States |
| Northeast Cincinnati Pediatric Assoc | Mason | Ohio | 45040 | United States |
| Red Lion Pediatrics | Philadelphia | Pennsylvania | 19114 | United States |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | United States |
| Austin Diagnostic Clinic | Austin | Texas | 78745 | United States |