The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

Mead Johnson Nutrition

Status: Completed

Conditions: Growth of Term Infants

Treatments: Other: An investigational infant formula containing a probiotic source; Other: Control: Marketed routine infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01897922

3385-2

Details and patient eligibility

About

This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.

Enrollment: 348 patients

Sex: All

Ages: 12 to 16 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton, 12-16 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Solely formula fed
• Signed Informed Consent and Protected Health Information

Exclusion criteria

• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Trial design

348 participants in 2 patient groups

Marketed routine infant formula

Active Comparator group

Treatment:

Other: Control: Marketed routine infant formula

Infant formula containing a probiotic source

Experimental group

Treatment:

Other: An investigational infant formula containing a probiotic source