Assessment of Growth of Infants Fed a New Formula

Assessment of Growth of Infants Fed a Starter Formula With a Whey-Isolate Enriched in Lactoferrin

The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day) of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the first four months of life as compared to infants fed a standard infant formula.

Inclusion Criteria:

• Healthy newborn infant
• Full-term (>37 weeks gestation)
• Birth weight between > 2500 and < 4500 g
• Infant's mother has elected not to breastfeed and baby has been exclusively formula fed a minimum 3 days prior to enrollment
• Tolerating a cows milk based formula for at least 3 days
• Study explained and written information provided with Parent/Caregiver demonstrating understanding of the given information
• Informed consent signed (Parent/Legal representative)
• Parent/Caregiver has a working freezer
• Lives within 45 minutes of a study site

Exclusion Criteria:

• Congenital illness or malformation that may affect infant feeding and/or normal growth
• Suspected or known allergy to cow's milk protein
• Significant pre-natal and/or post-natal disease
• Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
• Infant has received oral or intravenous antibiotic therapy in the 10 days prior to enrollment
• Infant receiving prescription medication (with exception of treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
• Infant currently participating in another clinical study
• Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol