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This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Marketed hypoallergenic infant formula containing a probiotic |
| |
| Experimental 1 | An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control |
| |
| Experimental 2 | An investigational hypoallergenic infant formula with a different protein content, without a probiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight measured at each study visit | 3.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recall of infant formula intake at each study visit | 3.5 months | |
| Body Length and Head Circumference measured at each study visit | 3.5 months | |
| Recall of stool characteristics and tolerance at each study visit |
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Inclusion Criteria:
Exclusion Criteria:
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Heatly, term infants
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Cooper, M.D. | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34289820 | Derived | Adams CB, Johnston WH, Deulofeut H, Leader J, Rhodes R, Yeiser M, Harris CL, Wampler JL, Hill RJ, Cooper T. Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial. BMC Pediatr. 2021 Jul 21;21(1):323. doi: 10.1186/s12887-021-02617-z. |
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| 3.5 months |
| Medically-confirmed adverse events collected throughout the study period | 3.5 months |
| Parental Product Assessment Questionnaire completed at Study Visit 2 | once |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Pediatrics East - Alabama Clinical Therapeutics | Pinson | Alabama | 35126 | United States |
| Central Arkansas Pediatric Clinic | Benton | Arkansas | 72019 | United States |
| The Children's Clinic of Jonesboro | Jonesboro | Arkansas | 72401 | United States |
| Arkansas Pediatric Clinic | Little Rock | Arkansas | 72205 | United States |
| Norwich Pediatric Group, P.C. | Norwich | Connecticut | 06360 | United States |
| Altamonte Pediatric Associates | Lake Mary | Florida | 32746 | United States |
| Children's Medical Association | Plantation | Florida | 33324 | United States |
| North Georgia Clinical Research Center/White's Pediatrics | Dalton | Georgia | 30721 | United States |
| Deaconess Clinic | Newburgh | Indiana | 47630 | United States |
| PTCU/Children and Youth Project | Louisville | Kentucky | 40202 | United States |
| Owensboro Pediatrics | Owensboro | Kentucky | 42303 | United States |
| Woburn Pediatric Associates | Woburn | Massachusetts | 01801 | United States |
| Gretchen Swanson Center for Nutrition | Omaha | Nebraska | 68105 | United States |
| Capital Pediatrics & Adolescent Center | Raleigh | North Carolina | 27609 | United States |
| Innovis Health South University | Fargo | North Dakota | 58103 | United States |
| Pediatric Associates of Mt. Carmel, Inc | Cincinnati | Ohio | 45245 | United States |
| Pediatric Associates of Fairfield, Inc | Fairfield | Ohio | 45014 | United States |
| Red Lion Pediatrics | Philadelphia | Pennsylvania | 19114 | United States |
| Primary Physicians Research, Inc | Pittsburgh | Pennsylvania | 15241 | United States |
| The Jackson Clinic - North Jackson | Jackson | Tennessee | 38305 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Austin Diagnostic Clinic | Austin | Texas | 78745 | United States |
| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005526 | Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
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