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To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Milk | Other | Reference group, breast feeding ad libitum |
|
| Control Formula | Active Comparator | Ready to feed infant formula, feed ad libitum |
|
| Experimental Formula 1 | Experimental | Ready to feed infant formula with human milk oligosaccharides, feed ad libitum |
|
| Experimental Formula 2 | Experimental | Ready to feed infant formula with human milk oligosaccharides, feed ad libitum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Formula | Other | Feeding ad libitum |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight gain per day | Study Day (SD) 14 - 119 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Characteristics | Stool consistency and number per day | Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits |
| Feeding Tolerance | % of feedings with spit up associated with feeding |
| Measure | Description | Time Frame |
|---|---|---|
| Study Formula Intake | Average volume of study formula intake and average number of study formula feedings per day | Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits |
| Oligosaccharides |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Williams, MPH | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35205 | United States | ||
| Alabama Clinical Therapeutics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37242222 | Derived | Hill DR, Buck RH. Infants Fed Breastmilk or 2'-FL Supplemented Formula Have Similar Systemic Levels of Microbiota-Derived Secondary Bile Acids. Nutrients. 2023 May 17;15(10):2339. doi: 10.3390/nu15102339. | |
| 27798337 | Derived | Goehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26. |
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| Experimental Formula 1 | Other | Feeding ad libitum |
|
| Experimental Formula 2 | Other | Feeding ad libitum |
|
| Human Milk | Other | Feeding ad libitum |
|
|
| Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits |
| Length | Length and interval length gain per day | Study Day (SD) 1, 14, 28, 42, 84 and 119 visits |
| Head Circumference | Head circumference (HC) and interval HC gain per day | Study Day (SD) 1, 14, 28, 42, 84 and 119 visits |
Infant urine sample
| Study Day (SD) 42 and 119 visits |
| Dothan |
| Alabama |
| 36305 |
| United States |
| W.O.M.B Watching Over Mothers and Babies | Tucson | Arizona | 85712 | United States |
| Clinical Research Advantage/Colorado Springs Health Partners | Colorado Springs | Colorado | 80920 | United States |
| Norwich Pediatric Group, PC | Norwich | Connecticut | 06360 | United States |
| Atlantic Clinical Research Collaborative | Boynton Beach | Florida | 33472 | United States |
| Lake Mary Pediatrics | Orange City | Florida | 32763 | United States |
| SCORE Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| USF, College of Medicine, Dept of Pediatrics | Tampa | Florida | 33606 | United States |
| Southeast Regional Research Group (SERRG) | Columbus | Georgia | 31904 | United States |
| PediaResearch, LLC | Evansville | Indiana | 47720 | United States |
| Northpoint Pediatrics, LLC | Indianapolis | Indiana | 46256 | United States |
| Lafayette Clinical Research | Lafayette | Indiana | 47905 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Dayton Clinical Research | Dayton | Ohio | 45406 | United States |
| Ohio Pediatric Research Association, Inc | Dayton | Ohio | 45414 | United States |
| Institute of Clinical Research | Mayfield Heights | Ohio | 44124 | United States |
| Clinical Trials of America | Eugene | Oregon | 97401 | United States |
| Red Lion Pediatrics | Philadelphia | Pennsylvania | 19114 | United States |
| Sanford Research | Sioux Falls | South Dakota | 65104 | United States |
| Tanner Memorial Clinic | Layton | Utah | 84041 | United States |
| Rockwood Clinic, PS | Spokane | Washington | 99202 | United States |
| Clinical Research Puerto Rico | Guayama | 00784 | Puerto Rico |
| Ponce School of Medicine/ CAIMED Center | Ponce | 00716 | Puerto Rico |
| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
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