Effect of Formula on Infant Behavior

Effect of Formula Supplemented With Oligosaccharides on Infant Behavior

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Inclusion Criteria:

• Subject is in good health as determined from subject's medical history by parent report
• Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
• Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.)
• Subject is between 7 and 42 days of age
• Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
• Infant is exclusively formula-fed at time of study entry
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
• Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

Exclusion Criteria:

• An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
• Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
• Subject participates in another study that has not been approved as a concomitant study
• Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment
• Subject has been treated with oral antibiotics within 7 days prior to study enrollment
• Mother intends to use a combination of breast and formula feeding