Impact of Infant Formula on Caregiver-perceived Intolerance

Impact of Infant Formula on Caregiver-perceived Intolerance

Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

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.