Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial

Open-label clinical trial to determine the effects of supplementing the probiotic Bifidobacterium longum subsp. infantis EVC001 for the first 21 days of life in healthy term breastfed infants compared with matched-control term infants receiving standard care. B. infantis EVC001 was found to be safely consumed and well-tolerated. Stools were fewer and better formed in infants in infants fed EVC001 group compared with exclusively breastfed controls. Adverse events were those expected in healthy infants and were not different between groups.