This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
48
fed ad libitum
Paramount Research Solutions
College Park, Georgia, United States
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Memphis & Shelby County Pediatric Group
Memphis, Tennessee, United States
Weight for Age
Change in weight for age z-score
Time frame: Study Day 1 to Study Day 60
Gastrointestinal Tolerance
Parent completed diary questions
Time frame: Study Day 1 to Study Day 60
Length
Gain measured in cm
Time frame: Study Day 1 to Study Day 60
Head Circumference
Gain measured in cm
Time frame: Study Day 1 to Study Day 60
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Ventavia Research Group, LLC
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States