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

Perrigo Nutritionals85 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Growth Healthy Term Infants

Interventions

Low Lactose Infant FormulaOTHER

Low Lactose Infant Formula

Eligibility

Sex: ALLMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

Accelovance Melbourne Site

Melbourne, Florida, United States

ACC Pediatric Research

Haughton, Louisiana, United States

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Research Across America

Dallas, Texas, United States

Outcomes

Primary Outcomes

Weight

Time frame: 16 weeks

Secondary Outcomes

Length gain

Time frame: 16 weeks

Occipital Head Circumference

Time frame: 16 weeks

Acceptability and Tolerability

Assessed by digestive tolerance; general health and well-being; adverse events; concomitant medications

Time frame: 16 weeks

Data from ClinicalTrials.gov

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