Clinical Research Directory

Inclusion Criteria: * 0-48 hours old; * Infants of both sexes with a birth weight ≥1000g; * Infants delivered by caesarean section; * Written informed consent from the infants' parents/guardians. Exclusion Criteria: * Vaginal delivery; * Extremely low birth weight (ELBW) (\<1000g); * Confirmed or suspected systemic infection; * Known severe neurological disease; * Known severe metabolic disease; * Known genetic disease and chromosome disorders; * Known severe maternal primary or secondary immunodeficiency; * Serious malformations (e.g. short bowel syndrome; intestinal occlusion; patency of the arterial duct may be included if asymptomatic and not requiring treatment); * Known maternal food allergies; * Maternal diabetes (including gestational diabetes); * Recent or suspected history of alcohol or drug abuse in the mother; * Any severe condition the investigator deems capable of interfering with treatment; * Inadequate reliability or presence of conditions capable of resulting in non-conformity or non-compliance of the patient with the protocol. * Administration of different probiotics other than the investigational product to the infant following start of the study. * Use of probiotics by a breastfeeding mother following start of the study. Only for NBW: * Systemic antibiotic treatment or prophylaxis from birth and throughout the duration of the study; * Systemic antibiotic treatment or prophylaxis by a breastfeeding mother (of an NBW infant) over the 30 days prior to the trial and throughout the duration of the study.