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Probiotic supplementation in very low birth weight infants: A single center experience in safety, tolerability, and necrotizing enterocolitis

Journal of Perinatology volume 46, pages 476–478 (2026)Cite this article

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In 2016, the University of Cincinnati Medical Center (UCMC) Newborn Intensive Care Unit (NICU), a 60-bed Level III NICU, engaged regionally with other NICUs in formalized systematic quality improvement (QI) work to reduce rates of Necrotizing Enterocolitis (NEC) in very low birth weight (VLBW) infants. Even with significant improvements in NEC rates, the overall incidence remained high relative to peer institutions [1]. In light of increasing reports of probiotics being adopted as a strategy to prevent NEC [2,3,4] the UCMC NICU began a QI initiative to implement live biotherapeutics in 2021. The objective of this report is to add to the ongoing discussion about the risks and benefits of probiotics in preterm infants.

The aims of our QI initiative were to (1) increase the use of probiotics in eligible patients from 0 to 80%, and (2) decrease the rate of NEC from 0.18 to 0 (VON median for VLBW infants) per 100 VLBW days. A commercially available probiotic formulation was selected through careful review of the literature (FloraTummys Probiotic, Bifidobacter infantis, Lactobacillus reuteri, 2 billion CFUs Quick Dissolve Tablet, NutraFana Nutraceuticals, North Bergen, NJ). In August 2021, unit-wide probiotic supplementation was initiated in neonates born at <32 weeks GA and/or 1500-gram birthweight, after parenteral assent. Probiotic supplementation was halted in October 2023 following FDA advisory cautioning against the use of probiotics in preterm neonates [5]. Key QI interventions included: standardization of inclusion and exclusion criteria, development of educational information for families including scripted assent, standardization of stringent administration techniques, and safety monitoring including microbiologic surveillance capability to identify suspected cases of probiotic-related sepsis. Process and outcome measures were tracked via run and control charts. The main outcome measure was analyzed with a U chart (NEC cases per 100 VLBW days).

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Data will be made available upon reasonable written request to the corresponding author.

References

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Acknowledgements

We thank our colleagues in the University of Cincinnati Neonatal Intensive Care Unit for supporting this initiative. A special thank you to Heather Tanner, our family representative and mother to Colton Tanner. She contributed valuable feedback to our team from the perspective of a mother to a son that survived NEC.

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Authors and Affiliations

  1. Perinatal Institute, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

    Nicole Comley, Henry Akinbi, Heather C. Kaplan, Jae Kim, Ting Ting Fu, Amy T. Nathan, Vivek Narendran & Laura Ward

  2. Department of Pharmacy Services, University of Cincinnati Medical Center, Cincinnati, OH, USA

    Afshin Taleghani

  3. University of Cincinnati, James L. Winkle College of Pharmacy, Cincinnati, OH, USA

    Afshin Taleghani

  4. Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA

    Henry Akinbi, Heather C. Kaplan, Jae Kim, Ting Ting Fu, Amy T. Nathan, Vivek Narendran & Laura Ward

  5. James M. Anderson Center for Health Systems Excellence, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

    Heather C. Kaplan

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  1. Nicole Comley
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  2. Afshin Taleghani
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  7. Amy T. Nathan
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Contributions

All authors participated in study design. NC, AT, and HA drafted the initial manuscript. NC, ATN, and HCK performed data analysis and interpretation of the results. All authors participated in the quality improvement work, critically reviewed and revised the manuscript, and approved the final manuscript as submitted.

Corresponding authors

Correspondence to Nicole Comley or Afshin Taleghani.

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Competing interests

Disclosures: Jae Kim, MD is an unpaid advisor to the NEC Society, has sponsored research from Fresenius-Kabi, is a consultant for Infant Biotherapeutics Cardinal Health, Biomilq, Carag, and Mothers Milk is Best. He also holds stock in Astarte Medical and Nicolette. Ting Ting Fu, MD has a speaking agreement with Medela.

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IRB approval was not required based on our local hospital policies.

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Comley, N., Taleghani, A., Akinbi, H. et al. Probiotic supplementation in very low birth weight infants: A single center experience in safety, tolerability, and necrotizing enterocolitis. J Perinatol 46, 476–478 (2026). https://doi.org/10.1038/s41372-025-02531-7

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