This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
115
method A phytate reduction and 5% protein hydrolysis
method A phytate reduction and 10% protein hydrolysis
method B phytate reduction and 5% protein hydrolysis
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Dreyer Clinic
Aurora, Illinois, United States
T&W Research
Owensboro, Kentucky, United States
Park Nicollet Medical Foundation
Minneapolis, Minnesota, United States
Stool Characteristics Questionnaire
stool number, consistency, and color
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Formula Intake
volume consumed
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Gastrointestinal Tolerance Questionnaire
Incidence of spit up and vomiting
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Weight
weight and weight gain
Time frame: Change from Baseline (Study Day 1) to Study Day 15
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Ready-to-Feed (RTF) Soy Infant Formula
Clinical Studies, Inc
Canton, Ohio, United States
Research Memphis
Memphis, Tennessee, United States
Child Care Associates
San Antonio, Texas, United States