Growth and Tolerance of Young Infants Fed Infant Formula

Study Overview
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Brief Summary
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This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.

Official Title
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Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides

Conditions
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Growth and Tolerance

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is judged to be in good health as determined from participant's medical history. 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) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study. Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study. Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study. Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable). Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or 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), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance. Participant participates in another study that has not been approved as a concomitant study.

Ages Eligible for Study
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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 |
| --- | --- |
| Active Comparator: Control Infant Formula<br>Milk-based study product | Other: Control Infant Formula<br>* Ready to feed infant formula, feed ad libitum<br>|
| Experimental: Experimental Infant Formula<br>Milk-based study product with oligosaccharides | Other: Experimental Infant Formula<br>* Ready to feed infant formula, feed ad libitum<br>|
| No Intervention: Reference Group<br>Human milk-fed group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight gain per day | Day of life 14 to Day of life 119 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Characteristics | Parent completed diary | Study Day 1 to Day of life 119 | 
| Formula Tolerance | Parent completed diary | Study Day 1 to Day of life 119 | 
| Length | Length gain per day | Day of life 14 to Day of life 119 | 
| Head Circumference (HC) | HC gain per day | Day of life 14 to Day of life 119 |