Growth and Tolerance of Hypoallergenic Formulas

Mead Johnson Nutrition

Status: Completed

Conditions: Growth of Term Infants

Treatments: Other: Infant formula

Study type: Observational

Funder types: Industry

Identifiers

NCT01354366

3383-1

Details and patient eligibility

About

This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.

Enrollment: 511 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

511 participants in 3 patient groups

Control

Description:

Marketed hypoallergenic infant formula containing a probiotic

Treatment:

Other: Infant formula

Experimental 1

Description:

An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control

Treatment:

Other: Infant formula

Experimental 2

Description:

An investigational hypoallergenic infant formula with a different protein content, without a probiotic

Treatment:

Other: Infant formula