This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
264
Sole source infant nutrition for the control arm.
Sole source infant nutrition for the cow milk test arm.
Sole source infant nutrition for the goat milk test arm.
ObvioHealth USA, Inc.
New York, New York, United States
RECRUITINGGrowth as compared against WHO growth charts
Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16
Time frame: 16 weeks
Safety
Adverse Events reported over the 16-week study period (+4 days) for all groups
Time frame: 16 weeks
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