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Since the PROPATRIA-trial in 2008, probiotics have been placed under scrutiny and concerns have been raised regarding the safety of administration of live microorganisms. When probiotics are administered to immune-incompetent or immune-deficient individuals, probiotic strains can potentially cause systemic infections. As probiotic intake and gut modulation might be most effective early in life, no uncertainties should remain regarding safety administration of probiotics during the perinatal period and childhood. This chapter provides a comprehensive overview of the safety of probiotics based on data from clinical trials up to 2016. These studies indicate that probiotics are safe for infants and children, even in frail preterm infants.