535 - Implementation and De-implementation of Probiotics in Neonatology Practice in the United States

Poster Number: 535
Publication Number: 535.1915

Background: Many ineffective or harmful practices were rapidly adopted in neonatology practice, and effective practices were adopted slowly, or never adopted. There is moderate to high-certainty evidence that probiotics decrease NEC, sepsis, feeding intolerance and mortality in preterm infants. However, the uptake of probiotics in practice in the US has been slow. Factors influencing their use have not been described.

Objective: To describe the major events that hastened and slowed down the adoption of probiotics into neonatology practice over the past two decades in the United States.

Design/Methods: Review of published literature, including systematic reviews and guidelines, web search, and search of social media posts to identify the key events influencing the use of probiotics in practice in the US.

Results: Influences promoting the use of probiotics were an updated Cochrane systematic review in 2020 and 2023, statements by The American Gastroenterological Association (2020), European Society for Paediatric Gastroenterology Hepatology and Nutrition (2020), European Society for Paediatric Gastroenterology Hepatology and Nutrition (2020), NEC society (2021), Canadian Paediatric Society (2022), World Gastroenterology Association (2023), and the International Scientific Association for Probiotics and Prebiotics (2023); and the creation of a 'probiotics toolkit' by the NEC Society.
Influences hindering the adoption of probiotics were a statement by the American Academy of Pediatrics Committee on Fetus and Newborn in 2021, FDA alerts about deaths due to probiotics in 2014 and September 2023 and subsequent warning against routine use, and in October 2023, postings on websites of legal firms offering consultations to parents of babies harmed by probiotics, multiple media reports highlighting the contents of the FDA alerts, and an FDA warning letter to the manufacturer of a commercial multi-strain probiotic product, and an update by the NEC society to their statement, stating they ‘neither advocate for or against’ the prophylactic use of probiotics in preterm infants.

Conclusion(s): Over the past two decades, the volume and quality of evidence favoring the use of probiotics have increased. However, concerns about the lack of a standard product and about safety have prevented their dissemination. The recent warnings from the FDA are likely to stop their use completely in the US. Major influences on adoption have been differing expert views on certainty of the evidence, about estimates of benefits versus risks, and statements by authoritative organizations.