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To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk based formula A | Experimental | Experimental milk based infant formula |
|
| Standard formula | Active Comparator | standard milk based infant formula |
|
| Reference | Other | Human milk |
|
| Milk based formula C | Experimental | Experimental milk based infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milk based formula A | Other | feed as per HCP directions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean rank stool consistency (MRSC) | Study Day 1 to Visit 3 |
| Measure | Description | Time Frame |
|---|---|---|
| MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timberly A. Williams, M.S. | Abbott Nutrition, Abbott Laboratories | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pediatric Clinic | North Little Rock | Arkansas | 72117 | United States | ||
| USF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25061716 | Derived | Williams T, Choe Y, Price P, Katz G, Suarez F, Paule C, Mackey A. Tolerance of formulas containing prebiotics in healthy, term infants. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):653-8. doi: 10.1097/MPG.0000000000000513. |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| #2 Standard formula | Other | Feed as per HCP directions |
|
|
| #3 Human Milk | Other | Feed as per HCP directions |
|
|
| Milk based formula C | Other | Feed as per HCP direction |
|
|
| Tampa |
| Florida |
| 33606 |
| United States |
| North Georgia Clinical Research, White's Pediatrics | Dalton | Georgia | 30721 | United States |
| Medical Associates Clinic | Dubuque | Iowa | 52001 | United States |
| Midwest Children's Health Research Institute, LLC | Lincoln | Nebraska | 68505 | United States |
| The Childrens Medical Group LLC | Poughkeepsie | New York | 12603 | United States |
| Levine Childrens Hospital | Charlotte | North Carolina | 28207 | United States |
| Ohio Pediatrics, Inc. | Huber Heights | Ohio | 45424 | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | 44124 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 78508 | United States |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |