Assessing Early Behavioral Indicators of Formula Tolerance

Assessing Early Behavioral Indicators of Formula Tolerance

The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

Inclusion Criteria:

• Singleton at birth
• Term infant with birth weight of 2500 g or more
• Crying or fussing for 3 or more hours per day
• Consuming mostly infant formula
• Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

• Current use of extensively hydrolyzed or amino acid infant formula
• Planned use of probiotics during the study
• History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
• Enrollment in another interventional clinical research study