Safety and Efficacy Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Detailed Description
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Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

Official Title
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Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial

Conditions
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Infant Term Birth

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines Infants whose parent(s)/LAR are willing and able to comply with study requirements Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study Healthy term, singleton infant at birth Between 21 to 26 days post-natal age at enrollment visit Weight-for-length and head circumference-for-age z-scores >/= - 3 and </= +3 according to WHO Child Growth Standards Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment Exclusion Criteria: Infants with conditions requiring infant feedings other than those specified in the protocol Infants receiving complementary foods or liquids Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results Infants who are presently receiving or have received medications that could interfere with the interpretation of study results Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures

Ages Eligible for Study
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Minimum Age: 21 Days
Maximum Age: 26 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>Experimental Infant Formula containing a prebiotic | Other: Experimental Infant Formula<br>* Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum<br>|
| Active Comparator: Standard Infant Formula<br>Standard bovine milk-based term infant formula | Other: Standard Infant Formula<br>* Standard bovine milk-based term infant formula, fed ad libitum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | weight gain velocity | 150 days | 
| Stool Consistency Score |  | 150 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | weight in grams | 150 days | 
| Average Daily Stool Frequency |  | 150 days | 
| Fecal Microbiota |  | 150 days | 
| Fecal Markers |  | 150 days | 
| Adverse Events |  | 150 days |