Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants

Conditions
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Infant Development

Intervention / Treatment
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* Other: BBN
* Other: Brand


Participation Criteria
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Eligibility Criteria
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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: Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant Have a birth weight of ≥ 2500 grams Designated as healthy by a physician ≤14 days post-natal age (Date of Birth = Day 0) Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment Only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole source of nutrition, will be approached for potential study enrollment Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study. 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: 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 Show evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician); Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases; Have a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is < 4300 g), active tuberculosis, perinatal infection, or substance abuse Have a family history of cow's milk protein intolerance/allergy Are an infant from a multiple birth (twin, triplet, etc.)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BBN<br>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. | Other: BBN<br>* BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.<br>* Other names: BBN-102;|
| Active Comparator: Brand<br>A commercially available Infant Formula, for healthy term infants 0 to 2 months of age (Enfamil TM, Milk-Based Powder with Iron). | Other: Brand<br>* Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks<br>* Other names: Enfamil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain | Change grams per day | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |