Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI

Abstract

The recent advisory issued by the United States Food and Drug Administration, cautioning against the routine administration of probiotics in preterm neonates, has sparked a lively debate within the scientific community. This commentary presents a perspective from members of the Special Interest Group on Gut Microbiota and Modifications within the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and other authors who contributed to the ESPGHAN position paper on probiotics for preterm infants, as well as representatives from the European Foundation for the Care of Newborn Infants. We advocate for a more nuanced and supportive approach to the use of certain probiotics in this vulnerable population, balancing the demonstrated benefits and risks.

Mitigating Intestinal Dysbiosis in the Very Preterm Infant

“…Evidence that intestinal dysbiosis precedes and is a risk factor for NEC in preterm infants includes observational studies of the fecal microbiota in infants with and without NEC [ 1 ], increased incidence of NEC with microbiota-altering interventions such as prolonged postnatal administration of antibiotics [ 2 ] and acid-blocking agents [ 3 ], and decreased incidence of NEC and death with administration of probiotics to preterm infants [ 4 ]. The latter has prompted conditional recommendations for routine probiotic prophylaxis for this high-risk group by the WHO, American Gastroenterological Association, and European Society for Paediatric Gastroenterology Hepatology and Nutrition, but not by the American Academy of Pediatrics or the FDA [ 5 ].…”