Safety and Efficacy Study

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

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

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.

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