Healthy Infants
Conditions
Brief summary
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms
Interventions
OTHERRoutine infant formula
Routine infant formula with probiotic
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Subjects and their parent/caregiver will be blinded to the intervention product. Care Providers at sites, Investigators, and Outcomes Assessors are unblinded to the intervention product.
Eligibility
Sex/Gender
ALL
Age
14 Days to 60 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy infant * Full-term (\> 37 weeks gestation) * Birth weight \> 2500 and \< 4500 g * 14-60 days of age on enrollment * Singleton birth * Infant's mother has elected not to breastfeed prior to enrollment * Infant exclusively formula-fed for at least 5 days prior to enrollment * Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days * Caregiver wishes to switch infant's formula * Has not received solid foods * Having obtained his/her legal representative's informed consent
Exclusion criteria
* Known or suspected cow-milk allergy * Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic) * Has switched formula more than two times since hospital discharge * Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu) * Congenital illness or malformation that may affect infant feeding and/or growth * Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment * Receiving probiotic supplements * Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen). * Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant GI Symptom Burden | 3 weeks | Study personnel will administer questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Formula Intake | 24 hours | Caregivers will document on diary records |
| Fussiness | 24 hours | Caregivers will document on diary records |
| Formula Satisfaction Questionnaire | 3 weeks | Study personnel will administer questionnaire |
| Adverse Events | 24 hours and 3 weeks | Assessed throughout study |
Countries
United States
Outcome results
None listed