Behavior of Infants Fed Formula Supplemented With Prebiotics

Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

Inclusion Criteria:

• Subject is judged to be in good health.
• Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
• Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
• Infant was identified by parents as very fussy or extremely fussy.
• Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
• 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.

Exclusion Criteria:

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect 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.