To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
feed as per HCP directions
Feed as per HCP directions
Feed as per HCP directions
The Pediatric Clinic
North Little Rock, Arkansas, United States
USF
Tampa, Florida, United States
North Georgia Clinical Research, White's Pediatrics
Dalton, Georgia, United States
Mean rank stool consistency (MRSC)
Time frame: Study Day 1 to Visit 3
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting
Time frame: 4 months
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Feed as per HCP direction
Medical Associates Clinic
Dubuque, Iowa, United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States
The Childrens Medical Group LLC
Poughkeepsie, New York, United States
Levine Childrens Hospital
Charlotte, North Carolina, United States
Ohio Pediatrics, Inc.
Huber Heights, Ohio, United States
Institute of Clinical Research
Mayfield Heights, Ohio, United States
Scott & White Memorial Hospital
Temple, Texas, United States