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

Mead Johnson Nutrition348 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

348

Conditions

Growth of Term Infants

Interventions

An investigational infant formula containing a probiotic sourceOTHER

Control: Marketed routine infant formulaOTHER

Eligibility

Sex: ALLMin age: 12 DaysMax age: 16 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (22)

Birmingham Pediatric Associates

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Body weight measured at each study visit

Time frame: 3.5 months

Secondary Outcomes

Recall of infant formula intake at each study visit

Time frame: 3.5 months

Body length measured at each study visit

Time frame: 3.5 months

Recall of stool consistency measured at each study visit

Time frame: 3.5 months

Medically-confirmed adverse events collected throughout the study period

Time frame: 3.5 months

Parental Study Product Assessment Questionnaire completed at Study Visit 2

Time frame: once

Head circumference measured at each study visit

Time frame: 3.5 months

Recall of gastrointestinal tolerance measured at each study visit

Time frame: 3.5 months

Data from ClinicalTrials.gov

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