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Evidence does not support routine probiotic use in preterm infants: AAP clinical report

May 24, 2021

Probiotics should not be given routinely to preterm infants, especially those weighing less than 1,000 grams, according to a new AAP clinical report.

Probiotics are considered dietary supplements, so they lack Food and Drug Administration labeling and cannot be marketed to treat or prevent diseases — such as necrotizing enterocolitis (NEC) and late-onset sepsis — in preterm infants. The number of preemies receiving probiotics in the U.S. and Canada is increasing steadily, despite conflicting data on their safety and efficacy, and potential for harm in a highly vulnerable population.

About 10% of infants with extremely low gestational age receive a probiotic preparation while in the neonatal intensive care unit, with wide variation in practice. Different products are being used in diverse settings and in diverse preterm populations. In addition, more than 10,000 premature infants worldwide have been enrolled in clinical trials of probiotic supplementation. The most recent trials have not shown a reduction in NEC in those at highest risk.

The report Use of Probiotics in Preterm Infants, from the Committee on Fetus and Newborn, is available at and will be published in the June issue of Pediatrics.

The report discusses the differences among commercially available probiotic preparations, potential risks of their use and the evidence in prevention and treatment of NEC and late-onset sepsis.


  • Because a pharmaceutical-grade probiotic product is not available in the U.S. and long-term safety is unknown, the report advises against routine, universal use of probiotics in preterm infants. Clinicians must be aware of the lack of regulatory standards for these preparations.
  • Centers that decide to administer probiotics to patients should discuss potential risks and benefits with parents. They should consider instituting an informed consent process, with guidelines addressing probiotic use and surveillance to assess local impacts. The introduction of probiotics has been shown to alter a center’s flora and potentially affect all infants cared for in the center. Therefore, centers should document outcomes, adverse events and safety.
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