Growth and Tolerance of Infants Fed Milk-Based Infant Formula

Study Overview
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Brief Summary
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The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.

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

Conditions
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Gastro-Intestinal Tolerance

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


Participation Criteria
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Eligibility Criteria
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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.) If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional. If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit 7. Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional. Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided 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 GI tolerance. Participant participates in another study that has not been approved as a concomitant study by AN.

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 infant formula | Other: Control Infant Formula<br>* Ready to feed infant formula, feed ad libitum<br>|
| Experimental: Experimental Infant Formula<br>Milk-based Infant Formula with oligosaccharides | Other: Experimental Infant Formula<br>* Ready to feed infant formula, feed ad libitum<br>|
| Other: Reference Group<br>Human-milk fed | Other: Reference Group<br>* Human milk, breast feeding ad libitum<br>|

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 - 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 | Study Day 1 to Day of life 119 | 
| Head Circumference (HC) | HC gain per day | Study Day 1 to Day of life 119 | 
| Illness Incidence | Parent reported incidence of illness | Study Day 1 to Day of life 119 |