Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Study Overview
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Brief Summary
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This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.

Official Title
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Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas

Conditions
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Infant Development

Intervention / Treatment
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* Other: Experimental Infant Formula
* Other: Control Infant Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is judged to be in good health Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks Participant's birth weight was > 2490 g ( 5 lbs. 8 oz.) Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization Exclusion Criteria: An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance Participant participates in another study that has not been approved as a concomitant study by AN. Participant has an allergy or intolerance to any ingredient in the study product Participant has been treated with antibiotics within 1 week prior to enrollment

Ages Eligible for Study
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Minimum Age: 0 Days
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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Infant Formula<br>extensively hydrolyzed casein protein | Other: Experimental Infant Formula<br>* Feed Ad Libitum<br>|
| Active Comparator: Control Infant Formula<br>extensively hydrolyzed casein protein | Other: Control Infant Formula<br>* Feed Ad Libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Interval weight gain per day | Day of Age (DOA) 14 to 119 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length | Interval length gain per day | Study Day (SD) 1 to DOA 119 | 
| Head Circumference | Interval HC gain per day | Study Day (SD) 1 to DOA 119 | 
| Stool Characteristics | Parent Completed Diary | Study Day (SD) 1 to DOA 119 | 
| Formula Intake | Parent Completed Diary | Study Day (SD) 1 to DOA 119 |