Probiotic Supplementation Linked to Lower Infant NEC Risks
A Swedish study found that daily probiotics reduced necrotizing enterocolitis and death rates in premature infants.
Updated on Sept. 30, 2026 in Babies
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Between 2017 and 2024, researchers analyzed data from 4,600 Swedish infants to determine the impact of a specific probiotic regimen. The findings showed a notable reduction in necrotizing enterocolitis and mortality rates among preterm infants who received the supplement.
Why it matters
Premature infants have immature intestines that are highly susceptible to necrotizing enterocolitis, a condition that can require surgery. This study highlights how altering the microbiome with beneficial bacteria may offer a protective strategy in neonatal care.
A registry-based study of 4,600 infants compared outcomes before and after the 2020 Swedish recommendation for probiotic use. While the results showed lower NEC and mortality rates, the specific long-term safety profile of these products remains a subject of regulatory investigation.
The players
American Academy of Pediatrics
A professional association of pediatricians that provides evidence-based clinical guidance on infant health.
FDA
The federal agency responsible for regulating food and drug safety, including the oversight of probiotic supplements.
Infant Bacterial Therapeutics
A pharmaceutical company developing a specific probiotic supplement currently under review by the FDA.
The details
The treatment regimen consisted of a daily dose of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus. These beneficial bacteria are intended to populate the infant microbiome, potentially creating a barrier against pathologic bacteria that lead to intestinal inflammation. Treatment began before day 4 of life and continued until the infant reached 34 weeks postmenstrual age.
Timeline
2017-2024: Study data collection period for Swedish infants.
2018-present: US adverse events reported related to probiotics.
2020: Sweden recommended probiotic use for premature infants.
2021: AAP stated evidence did not support routine probiotic use.
2023: FDA issued warnings regarding probiotic-linked sepsis.
Health Landscape
The study's findings regarding NEC risk reduction mark a departure from the American Academy of Pediatrics' 2021 position on routine probiotic administration, which noted insufficient evidence for the practice. Global neonatal practices remain divided as regulators continue to investigate the safety of these products.
Parents of premature infants should speak with their neonatologist about the risks and benefits of probiotic administration in the NICU setting. Given the FDA's warnings regarding potential infection risks, it is important to discuss the specific source and evidence behind any hospital protocols.
The takeaway
While early data suggests probiotics may protect premature infants against serious intestinal complications, they carry a risk of rare but fatal infections. Always consult with a specialized neonatal care team regarding the specific evidence supporting any treatment plan for a high-risk infant.
What happens next
The NICU community will be able to begin using probiotics if the Infant Bacterial Therapeutics supplement currently under FDA review is approved.
Further reading
Learn more about the latest research and clinical standards for newborns in our Babies section.
Source note: This article includes information reported by Medscape.
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