Crying
Conditions
Keywords
infants, formula, probiotic, crying
Brief summary
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.
Interventions
OTHERMilk based infant formula with probiotic
formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 4 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| daily total crying time | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Formula intake | 4 days |
| Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies | 4 days |
Countries
United States
Outcome results
None listed