Growth and Safety of a Low Lactose Milk-Based Infant Formula

Perrigo

Status: Completed

Conditions: Healthy Term Infants; Growth

Treatments: Other: Low Lactose Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497314

PRG-VA-12-001

Details and patient eligibility

About

The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.

Full description

Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.

Enrollment: 85 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy term infants
• birth weight 2500 - 4500 g
• singleton birth
• 37 - 42 weeks gestation

Exclusion criteria

• clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
• receiving medications other than vitamins

Trial design

85 participants in 1 patient group

Low Lactose Infant Formula

Other group

Treatment:

Other: Low Lactose Infant Formula