Probiotic Supplementation Linked to Lower Necrotizing Enterocolitis and Mortality in Very Preterm Infants

Swedish researchers examined very preterm infants (born at 28–31 weeks gestation) across neonatal intensive care units before and after a national rollout of a well-characterized probiotic formulation. The observational analysis compared outcomes in periods 2017-2019 (pre-probiotic) and 2021-2024 (post-probiotic). The study, published in *JAMA Network Open*, found that infants who received probiotics were less likely to develop severe necrotizing enterocolitis (NEC) or die than comparable infants who did not receive the supplement. No cases of probiotic-associated sepsis were reported.

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• Probiotic group: 1,571 infants; non-probiotic group: 3,124 infants.

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• Surgical NEC occurred in 1 infant receiving probiotics versus 40 infants without probiotics.

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• The combined rate of NEC or death was 0.8 % with probiotics and 2.9 % without, implying roughly 48 infants need probiotic treatment to prevent one additional case of NEC or death.

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He noted that Sweden’s emphasis on breast-milk feeding, family-centered care, and skin-to-skin contact may have amplified the benefit.

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Thao (Tina) Ho, associate professor and chief of neonatology at the University of South Florida Morsani College of Medicine, cautioned that the observational design cannot establish causality. She argued that other changes in neonatal care between the two periods could also have contributed to the improved outcomes and advised parents to discuss probiotic use with their medical team, emphasizing that over-the-counter products are not regulated for preterm infants.

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Mitha indicated that the unanswered question of probiotic efficacy in infants born before 28 weeks is being addressed by the PEPS trial, a large placebo-controlled randomized study conducted in Sweden and Denmark that has enrolled 535 infants to date.

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• “The direction of the association was not unexpected, as numerous randomized trials and meta-analyses have shown that probiotics benefit preterm infants,” — Ayoub Mitha, MD, PhD, the study's corresponding author

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• “This question is currently being addressed in the PEPS trial, a large placebo-controlled randomized trial conducted in Sweden and Denmark, which has so far enrolled 535 infants,” — Ayoub Mitha, MD, PhD, the study's corresponding author

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