A multi-center, prospective, randomized, controlled, doubleblind intervention clinical Trial is performed to proof the efficiency of hydrolyzed infant formula showing a risk reduction of developing an allergy.

Inclusion Criteria:

• Healthy term-born male and female infants (gestational Age ≥37+0, singleton birth)

• Birth weight ≥ 2500 g and ≤ 4500 g

• Age at enrollment: ≤ 56 days of life

• At risk of developing atopic diseases

• Free of atopy symptoms at Screening and at any time before randomization

• Feeding regimen at any time before Screening (V1) and Baseline (V2, infants who will receive Interventional Product (IP)): no infant formula feeding and solid foods allowed (in order to exclude prior sensitization) except amino acid formula (e.g. Neocate Infant), maltodextrin or glucose solution/gel; breastfeeding allowed

• Subject's parents/caregivers willing to comply with the feeding regimen during the intervention period. Subject's parents/caregivers will decide which feeding regimen will be used (IP or breast milk):

  • IP regimen (intervention or control group): only IP and breast milk until at least 120 days of life
  • breastfeeding regimen (reference group): exclusively breast milk until at least 120 days of life.
  • No other infant formulas or solid foods are allowed.

• Written informed consent.

Exclusion Criteria:

• Multiple births
• Premature delivery (gestational age ≤ 36+6)
• Neonatal illnesses that might have an impact on allergy development (based on Investigator's decision)
• Significant congenital abnormalities
• Participation in another clinical study with an IP or study method that would influence the outcome of this study
• Reason to presume that the subject's parents/caregivers are unable to meet study plan requirements.