American Academy of Pediatrics Issues Clinical Report Urging Caution in Use of Probiotics in Preterm Infants

The American Academy of Pediatrics has published a clinical report, “Use of Probiotics in Preterm Infants,” to provide guidance on the dietary supplement, which has not been approved by the U.S. Food and Drug Administration yet is increasingly given to preterm infants. The AAP, finding conflicting data on its safety and efficacy in this vulnerable population, does not support the routine, universal administration of probiotics to preterm infants, particularly those with birth weight <1000 g. Although some infant formulas for term infants in the United States now contain probiotics, formulas for preterm infants do not. The clinical report highlights differences among commercially available probiotic preparations and lack of regulatory standards in the United States. The report outlines potential risks associated with the use of probiotics with preterm infants and supports a cautionary approach, and reviews the current evidence evaluating use of probiotics in both prevention and treatment of necrotizing enterocolitis, late-onset sepsis, and mortality. The report also highlights the need for pharmaceutical grade probiotics that have been rigorously evaluated for safety and efficacy.

###

The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.