A multi-centre, randomised, double-blind, parallel-group, controlled, prospective, non-inferiority intervention clinical trial is performed to assess the safety and suitability of an infant formula manufactured from extensively hydrolysed protein by showing normal growth of healthy term infants during the first 120 days of life with an optional follow up until 180 days of life.
Since many years the use of infant formulae manufactured from hydrolysed proteins are recommended for infants at risk for developing allergies if they cannot be exclusively breast-fed. Although the use of such formulae manufactured from hydrolysed protein is legally authorized according to the respective legal framework since many years (currently: Directive 2006/141/EC), the safety of each hydrolysed protein has to be substantiated by additional clinical data according to new legal requirements (Del. Regulation (EU) 2016/127). This study is intended to generate clinical safety data: demonstrating adequate growth of infants fed a formula manufactured from hydrolysed protein in comparison to infants fed a formula manufactured from intact protein. As formula manufactured from hydrolyzed proteins is known to have beneficial effects on gastrointestinal comfort, it is also fed to infants not at risk for developing allergies. Therefore, this study additionally investigates the impact of hydrolysed protein on gastrointestinal tolerance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
360
Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (intervention formula manufactured from extensively hydrolysed whey protein).
Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (control formula manufactured from intact cow's milk protein).
Evangelisches Waldkrankenhaus Spandau
Berlin, Germany
Infant daily weight gain (in g/day) between 30 days and 120 days of age
Time frame: 90 days duration
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