Feeding Intervention for Infants With Crying

Nestlé

Status

Terminated

Conditions

Crying

Treatments

Other: Milk based infant formula with probiotic

Other: Milk based infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01017991

09.03.INF

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

3 weeks to 4 months old

Volunteers

Accepts Healthy Volunteers

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