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Probiotics and necrotizing enterocolitis in preterm infants after the food and drug administration warning actions

Veeral N Tolia1,2, Monica M Bennett3, Darren Handler4

  • 1Pediatrix Center for Research Education, Quality and Safety, Sunrise, FL, USA. veeraltolia@gmail.com.

Journal of Perinatology : Official Journal of the California Perinatal Association
|June 1, 2026
PubMed

Insights

Following FDA actions, probiotic use in preterm infants dropped significantly, leading to an increase in necrotizing enterocolitis (NEC) in high-use centers. Low-use centers saw no change in NEC rates.

Area of Science:

  • Neonatalogy
  • Gastroenterology
  • Public Health

Background:

  • Necrotizing enterocolitis (NEC) is a serious gastrointestinal condition affecting preterm infants.
  • Probiotics are often used to prevent NEC in vulnerable neonates.
  • FDA actions in 2023 prompted changes in clinical practice regarding probiotic use.

Purpose of the Study:

  • To assess the impact of FDA actions on probiotic use in preterm infants.
  • To evaluate the subsequent changes in necrotizing enterocolitis (NEC) incidence.
  • To compare NEC rates between high and low probiotic-use centers post-FDA action.

Main Methods:

  • Natural experiment observational study utilizing the Pediatrix Clinical Data Warehouse.
  • Comparison of NEC incidence in high probiotic-use centers (HUCs) versus low-use centers (LUCs).
  • Difference-in-differences analysis applied to data from October 2022 to March 2025.

Main Results:

  • Probiotic use dramatically decreased in HUCs (86% to 6.9%) post-FDA action, with a smaller decrease in LUCs (13% to 0.1%).
  • NEC incidence rose in HUCs (2.7% to 4.4%) but remained stable at 3.6% in LUCs.
  • An adjusted increase in NEC was observed in HUCs compared to LUCs (1.18%; P=0.045).

Conclusions:

  • Rapid cessation of probiotic use in centers with routine use was associated with increased NEC incidence.
  • These findings highlight the potential impact of practice changes on neonatal outcomes.
  • Further research is needed to understand the long-term implications and optimal strategies for NEC prevention.
Abstract

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