Probiotics remain inaccessible to preemies in the United States
The NEC Society brings together families, clinicians, and scientists around the globe under the shared vision of a world without necrotizing enterocolitis (NEC). As more premature infants survive at earlier gestations, NEC continues to devastate preemies worldwide. Yet, the type of care a preemie receives and their chance to thrive after a NEC diagnosis depend on where they are born and their access to protective care strategies. As we work tirelessly to advance the science necessary to eliminate the risks of NEC, it is imperative to utilize the most promising tools available today, including:
- Mother’s own milk
- Pasteurized donor human milk
- Targeted probiotic therapies supported by rigorous science
Despite supporting evidence, the protective benefits of probiotics remain inaccessible to preemies in the United States. Premature infants in the US have been without this protective strategy since the FDA’s Warning Letter in September of 2023 and the subsequent voluntary recalls. It has been nearly three years, and more premature infants in the US are dying as families wait for an FDA-approved, live biotherapeutic product for NEC.
Evidence Shows Probiotics Protect Preemies
Research continues to demonstrate that probiotics are an effective tool for reducing the risk of NEC and death in Very Low Birth Weight (VLBW) infants, with minimal risk of probiotic sepsis. Two major recent studies emphasize this protective power:
- Dr. Cheryl Battersby and Aveline et al. assessed data from over 48,000 infants born before 32 weeks gestation, and analyzed the direct impact of probiotics on severe NEC. Only 3.3% of babies who received probiotics developed severe NEC (surgical or postmortem), compared to 4.2% in babies who did not receive probiotics. Babies receiving probiotics had a lower risk of late-onset sepsis and a higher chance of surviving.
- The Connection Study, a multicenter clinical trial of over 2,100 VLBW infants, investigated the efficacy and safety of a live biotherapeutic product candidate, IBP-9414 (L. reuteri). While the primary endpoint did not reach statistical significance, a post hoc analysis at 14 days of treatment showed a significant result in cases of confirmed NEC by surgery or autopsy. Treatment with IBP-9414 significantly reduced all-cause mortality, proving that live biotherapeutic treatments can be a safe and effective tool to help prevent the most devastating outcomes in VLBWs. Although IBP-9414 gained Breakthrough Therapy Designation in 2025, it awaits final approval, with families, clinicians, and the NEC Society community calling for urgent regulatory action.
Failing to Translate Science into Protective Care
Drs. Sreekanth Viswanathan and Kanekal Suresh Gautham recently reviewed the evidence and international guidance on probiotics, calling for a paradigm shift in the US. In the Journal of Perinatology, they emphasize:
“The current situation in the United States represents a critical failure to translate overwhelming scientific evidence into life-saving clinical practice….The risk of an extremely rare case of probiotic sepsis does not justify accepting the certainty of far more frequent cases of NEC and death that will occur in the absence of prophylaxis. There is an urgent need for clinicians, researchers, regulatory bodies, manufacturers, and parent advocates to collaborate on a path forward.”
NEC Society's Commitment to Families
The NEC Society is dedicated to preventing necrotizing enterocolitis and improving outcomes for every baby in the NICU. Preventing NEC requires clinicians and patient-families to work together, in accordance with regulatory governance, to carefully consider the risks and benefits of available approaches, including probiotics. Families need clear, evidence-based information, honest conversations, a meaningful partnership in care decisions, and access to science-supported protective care strategies. NEC is often a life-altering diagnosis for families, with high morbidity and mortality rates. Families who face the challenges and uncertainties of premature birth urgently need the broader community to harness the power of science to implement the most protective care for every baby. The NEC Society—representing families affected by NEC and the clinician-researchers working tirelessly to care for neonates in their units—continues to strongly urge the FDA to authorize a pathway for probiotics with demonstrated safety and evidence of improved outcomes. Our babies cannot wait.
Join the Movement for a World without NEC
- Wala SJ, Ragan MV, Pryor E, Canvasser J, Diefenbach KA, Besner GE. Contemporary use of prophylactic probiotics in NICUs in the United States: a survey update. J Perinatol. 2024;44(5):739-744. doi:10.1038/s41372-024-01952-0
- https://public.vtoxford.org/nicu-by-the-numbers/probiotic-exposure-varies-internationally/
- Aveline A, Szatkowski L, Berrington J, et al. Evaluating the effect of probiotics on severe necrotising enterocolitis in preterm infants born before 32 weeks gestation in England and Wales: a propensity-matched population study. Lancet Reg Health Eur. 2026;62:101571. doi:10.1016/j.lanepe.2025.101571
- Neu J, Del Moral T, Guthrie SO, et al. Live biotherapeutic product IBP-9414 (L. reuteri) in very low birth weight infants: the Connection Study. Pediatr Res. Published online February 20, 2026. doi:10.1038/s41390-026-04826-7
- Viswanathan S, Gautham KS. Navigating the United States FDA advisory: Probiotics in Preterm Infants. J Perinatol. Published online February 3, 2026. doi:10.1038/s41372-026-02574-4
The NEC Society is the world’s leading nonprofit organization dedicated to necrotizing enterocolitis, working tirelessly to advance research, education, and advocacy.
