Feeding Intervention for Infants With Crying

Inclusion Criteria:

• full term infants greater than or equal to 37 wks gestation
• 3 weeks to less than or equal to 4 months of age upon enrollment
• experiencing ongoing crying and fussy episodes of a minimum of 3 hours of crying /day for 3 days in a week for at least one week prior to enrollment
• otherwise healthy as reported by parent/caregiver
• is under the care of a pediatrician or other qualified healthcare professional and has had at least one postnatal visit
• taking no more than one feeding of breast milk per day
• having not initiated weaning foods or beverages other than infant formula or breast milk
• study explained and written information provided with Parent/caregiver demonstrating understanding of the given information
• informed consent signed(parent/legal representative)

Exclusion Criteria:

• Chromosomal or major congenital anomalies
• known cow's milk allergy
• receiving any type of therapeutic formula (including extensively hydrolyzed formula or free amino acid formula)
• receiving an antibiotic or probiotic in the week prior to enrollment
• complicated reflux, defined by reflux combined with inadequate growth and/or respiratory complications
• infant's family, who in the investigator's assessment, cannot be expected to comply with the protocol
• infant currently participating in another conflicting clinical study