Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).

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 study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.

Official Title
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Comparative Effects of Cow's Milk Based Infant Formula Containing Both OPO and CPP Versus Non-OPO Formula and Breast Feeding on Growth, Stool Consistency and Bone Strength: A Double-blinded, Randomized and Controlled Study

Conditions
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Infant Development

Intervention / Treatment
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* Other: Study Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 days of age at randomization, inclusive (day of birth is considered day 0) Exclusively formula-fed or partially bottle feeding with intake more than 650 ml /day for at least 3 days prior to randomization Exclusively breast fed for at least 7 days prior to randomization Singleton birth Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks of gestational age) Birth weight of 2500g to 4000g Signed informed consent obtained for infant's participation in the study Parent or guardian of infant agrees not to enroll infant in another interventional clinical research study while participating in this study Exclusion Criteria: History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion) Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%] Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others Participation in another clinical trial Known or increased risk of cow's milk allergy and/ or lactose intolerance (i.e. one of the biological parents and or siblings diagnosed with cow's milk allergy, asthma, hay fever, etc.) Having a mother suffering from diabetes during pregnancy Use of antibiotics at the time of screening, or during the past two weeks

Ages Eligible for Study
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Minimum Age: 14 Days
Maximum Age: 30 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Formula<br>a Cow's Milk Based Infant Formula Containing Both OPO and CPP for term infants (JunLeBao ZhiZhen) | Other: Study Formula<br>* Study infant formula for term infants containing OPO and CPP<br>|
| Active Comparator: Comparator Formula<br>Commercially available infant formula without OPO for term infants (JunLeBao LeChun) | Other: Study Formula<br>* Study infant formula for term infants containing OPO and CPP<br>|
| No Intervention: Human Milk Reference Group<br>Human milk | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric parameters | Achieved body length (cm) and rate of gain | 1month to 5 months | 
| Anthropometric parameters | Achieved body weight (kg) and rate of gain | 1month to 5 months | 
| Anthropometric parameters | Achieved head circumferences (cm) and rate of gain | 1month to 5 months | 
| Stool characteristics | Infant Stool Form Scale to measure stool consistency (Bekkali et al, 2009): 4-point scale as watery (A) soft (B) formed (C) or hard (D) | 1 month to 5 months | 
| Stool characteristics | Infant Stool Form Scale to measure stool amount (Bekkali et al, 2009): 4-pont scale as smear (1), up to 25% (2), 25-50% (3) or >50% (4) | 1 month to 5 months | 
| Stool characteristics | Infant Stool Form Scale to measure stool color (Bellali et al, 2009): 6 categories as yellow (I), orange (II), green (III), brown (IV), meconium (V) or clay-colored (VI) | 1 month to 5 months | 
| Gastrointestinal tract discomfort | frequency of parents observed and documented GI tract discomfort | 1 month to 5 months | 
| Bone Speed Of Sound | Ultrasound Bone Densitometer (BMD-A3) | at 1 month and 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula intake and tolerance (24 hour dietary recall) | ml /day | 2 months to 5 months | 
| Medically-diagnosed adverse events collected throughout the study period | frequency | 1 month to 5 months | 
| Crying and sleep tracking (24 hours recall) | frequency | 2 months to 5 months | 
| Bone Mineral Content/Density | DEXA | at 5 months |