This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
113
Feed ab libitum
Feed ab libitum
Arkansas Children's Hospital
Little Rock, Alaska, United States
Aurora Pediatric Associates
Aurora, Colorado, United States
Northlake Pediatric, Associates
Stone Mountain, Georgia, United States
The Medical Associates Clinic
Dubuque, Iowa, United States
Stool Characteristics
Parent questionnaire
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Formula Intake
Parent questionnaire on volume consumed
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Incidence of spit up/vomiting
Parent questionnaire
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Weight
Measured weight at visits
Time frame: Change from Baseline (Study Day 1) to Study Day 15
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Baystate Medical Center, Children's Hospital
Springfield, Massachusetts, United States
Clinical Studies, Inc
Canton, Ohio, United States
Richmond Pediatrics
Richmond, Virginia, United States
Optimum Clinical Research
Oshawa, Canada