Happy Smooth Study

Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial

The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.

Inclusion Criteria:

• Written Informed Consent
• Infants whose parents/LAR have reached the legal age of majority in the Philippines
• 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
• Healthy term, singleton infant at birth
• Between 21 to 28 days post-natal age at enrollment visit
• Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
• 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 the study results