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| Name | Class |
|---|---|
| Paidion Research, Inc. | INDUSTRY |
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A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.
This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a experimental infant formula, formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks; infant growth, serum markers for inflammation and tolerance to the formulas will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBN | Experimental | An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age with Sn-2 Palmitate, Alpha Lactalbumin and Lactoferrin to better mimic human milk. |
|
| Brand | Active Comparator | A commercially available Infant Formula, for healthy term infants 0 to 2 months of age (Enfamil TM, Milk-Based Powder with Iron). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBN | Other | BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | Change grams per day | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean stool consistency | 1= watery, 2= runny / soft, 3= mushy / soft, 4= formed soft, 5= hard | 16 weeks |
| Mean fussiness score | 0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal |
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Infants will be eligible to participate if they meet all of the following conditions. At birth, the infant must be:
Inclusion Criteria:
Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kumar Ilangovan, MD | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAS Research | Tampa | Florida | 33613 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24840511 | Result | Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443. |
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| ID | Term |
|---|---|
| C083544 | lepirudin |
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Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks.
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This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants.
| Brand | Other | Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks |
|
|
| 16 weeks |
| Mean gassiness score | 0= no gas, 1= slight amount of gas, 2= moderate amount of gas, 3= excessive amount of gas | 16 weeks |
| Mean interleukin - 6 Concentration | IL - 6 ng/ml | 16 weeks |
| Mean interleukin - 10 Concentration | IL - 10 pg/ml | 16 weeks |
| Mean tumor necrosis factor alpha concentration | TNF - alpha pg/ml | 16 weeks |