Growth of Infants Fed a New Term Infant Formula

Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

Inclusion criteria

• Written informed consent signed and dated
• Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
• Infants whose parent(s)/LAR have a working freezer.
• Healthy term, singleton infant at birth.
• At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
• At enrollment, birth weight ≥ 2500g and ≤ 4500g.
• For formula-fed group, infant 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 prior to enrollment medications that could interfere with the interpretation of study results.
• Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.