This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein formula.
The main purpose of this study is to demonstrate adequate growth over a 16-week intervention period in cow's milk allergic infants receiving a hydrolyzed protein formula.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
69
The subjects will take the formula for 16 weeks
Promed Medical Centre
Krakow, Poland
Adequate growth
Proportion of subjects with growth classified as adequate (by interpreting WHO z-scores weight-for-age and weight-for-length)
Time frame: 16 weeks
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