Tolerance of Healthy Term Infants Fed Infant Formulas

Abbott Nutrition190 enrolled

Overview

The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

190

Conditions

Infant, Newborn

Interventions

milk protein formulas, varying carbohydrate/protein sourcesOTHER

ad lib for 0-8 days of age until 28 days of age

Eligibility

Sex: ALLMax age: 8 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy, term infants; singleton birth; 37-42 weeks of age; \>2490gms at birth; 0-8 days of age Exclusion Criteria: * medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth

Locations (15)

Global Clinical Investigation

Aventura, Florida, United States

University of South Florida

Tampa, Florida, United States

Outcomes

Primary Outcomes

Gastrointestinal tolerance

Time frame: 0-8 days of age until 28 days of age

Secondary Outcomes

GI and intake parameters

Time frame: 0-8 to 28 days of age

Data from ClinicalTrials.gov

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