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The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk Based Protein Formula Process A | Experimental |
| |
| Milk Based Protein Formula Process B | Experimental |
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| Milk Based Protein Formula Process C | Experimental |
| |
| Milk Based Protein Formula Process D | Experimental |
| |
| Milk Based Protein Formula Process E | Experimental |
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| Milk Based Protein Formula Process F | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental milk protein infant formula Process A | Other | ad lib for 1-8 days of age until 28 days of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary variable is Gastrointestinal tolerance. | 1-28 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary variables are additional measures of GI tolerance and parental feedback. | 1-28 days of age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caude T Ashley, MD | Alabama Clinical Therapeutics, LLC | Principal Investigator |
| Terri L Ashmeade, MD | USF Department of Pediatrics | Principal Investigator |
| Jay Cohen, MD | Discovery Clinical Research, Inc. | Principal Investigator |
| Timothy Crum, MD | Rockwood Clinic | Principal Investigator |
| Cole Ezeoke, MD | North Georgia Clinical Research, White's Pediatrics | Principal Investigator |
| Sharon Groh-Wargo, PhD, RD, LD | MetroHealth Medical Center | Principal Investigator |
| James Guerrieri, MD | Institute of Clinical Research, LLC | Principal Investigator |
| James Hedrick, MD | Kentucky Pediatric Research | Principal Investigator |
| Jeffrey Hirschfield, MD | SCORE Physician Alliance, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Dothan | Alabama | 36305 | United States | ||
| All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929831 | Derived | Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2. |
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| Experimental milk protein infant formula Process B | Other | ad lib from 1-8 days of age until 28 days of age |
|
| Experimental milk protein infant formula Process C | Other | ad lib from 1-8 days of age to 28 days of age |
|
| Experimental milk protein infant formula Process D | Other | ad lib from 1-8 days of age until 28 days of age |
|
| Experimental milk protein infant formula Process E | Other | ad lib from 1-8 days of age until 28 days of age |
|
| Experimental milk protein infant formula Process F | Other | ad lib from 1-8 days of age until 28 days of age |
|
| Kevin Mullen, MD |
| Medical Associates Clinic, PC |
| Principal Investigator |
| Chris Peltier, MD | Pediatric Associates of Mount Carmel, Inc. | Principal Investigator |
| Martin J Schear, MD | Dayton Clinical Research | Principal Investigator |
| Julie Shepard, MD | Ohio Pediatric Research Association | Principal Investigator |
| William Stepp, MD | Sarah Cannon Research Institute, LLC | Principal Investigator |
| L Louise Tetrick, MD | Northpoint Pediatrics | Principal Investigator |
| Plantation |
| Florida |
| 33324 |
| United States |
| SCORE Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| North Georgia Clinical Research | Dalton | Georgia | 30721 | United States |
| Northpoint Pediatrics, LLC | Indianapolis | Indiana | 46038 | United States |
| Medical Associates Clinic, PC | Dubuque | Iowa | 52001 | United States |
| Kentucky Pediatric / Adult Research | Bardstown | Kentucky | 40004 | 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, Inc. | Huber Heights | Ohio | 45424 | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | 44124 | United States |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | United States |
| Rockwood Clinic North - Pediatrics | Spokane | Washington | 99218 | United States |