Feeding Intervention for Infants With Crying

Effects of an Infant Formula With Probiotics on Signs and Symptoms of "Colic".

The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.

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