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To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.
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Inclusion and exclusion criteria
Inclusion criteria (formula-fed group):
healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days
Inclusion criteria (breast-fed group):
healthy infants exclusively breast-fed from birth and mothers intending to breastfeed >80% until at least 5th month of age (meaning through the 4th month of age).
Inclusion criteria (all infants):
delivered between 37 and 42 weeks of gestation birth weight >2500 g and <4000 g parent or the subject's legal representative speak and understand Chinese
Exclusion criteria (formula-fed group):
fully or partially breast-fed infants infants breast-fed >20%
Exclusion criteria (breast-fed group):
infants fed >20% infant formula
Exclusion criteria (all infants):
malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics
Primary purpose
Allocation
Interventional model
Masking
800 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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