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
The AAP, finding conflicting data on its safety and efficacy in this vulnerable population, does not support routinely giving probiotics to preterm infants, particularly those with birth weight <1000 grams (2.2 pounds).
Although some infant formulas for full-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. It outlines potential risks associated with the use of probiotics with preterm infants and support a cautious approach.
Authors of the report review the current evidence evaluating use of probiotics in both prevention and treatment of necrotizing enterocolitis, late-onset sepsis, and mortality. They also highlights the need for pharmaceutical grade probiotics that have been rigorously evaluated for safety and efficacy.