Gastrointestinal Tolerance Evaluation of an Infant Formula

Infant Formula GI Tolerance Evaluation

Prospective, double-blind, randomized study of 2 infant formulas.

Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.

Inclusion Criteria:

• Healthy newborn singleton infant
• Full-term (> 37 weeks gestation)
• Birth weight ≥ 2500 grams and ≤ 4500 grams
• 9-19 days of age on enrollment
• Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
• 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. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
• Currently not tolerating (as perceived by the caregiver) their formula
• Currently being treated for reflux
• Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going 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 prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
• 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.