Healthy Term Infants Fed Milk-Based Infant Formula

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Official Title
-----------------
Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides

Conditions
-----------------
Tolerance

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health as determined from participant's medical history Singleton from a full-term birth with a gestational age of 37-42 weeks 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 vitamin or mineral supplements, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study 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 (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance Participant is enrolled in another study that has not been approved as a concomitant study

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Infant Formula<br>Feed ad libitum | Other: Control Infant Formula<br>* Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide<br>|
| Experimental: Experimental Infant Formula<br>Feed ad libitum | Other: Experimental Infant Formula<br>* Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean rank stool consistency (MRSC) | Parent Completed Diary | Study Day 1 to 28 Days of Age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Interval weight gain per day | 14 to 119 Days of Age | 
| Gastrointestinal tolerance | Parent Completed Diary | 14 to 119 Days of Age | 
| Length | Interval length gain per day | 14 to 119 Days of Age | 
| Head Circumference | Interval head circumference gain per day | 14 to 119 Days of Age |