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How accurate are labels of probiotic products marketed to infants?

Pediatric Research volume 98, pages 22–24 (2025)Cite this article

Probiotics might prevent a variety of infant disorders, including colic, food allergy, atopic dermatitis, antibiotic-associated diarrhea, and necrotizing enterocolitis (NEC).1,2,3,4,5,6 Use is widespread despite unanswered questions regarding efficacy and safety.7,8 Commercially available probiotic products include a wide variety of single or multiple strains that can be administered in a range of doses and durations of therapy.2,5,9 Choosing a safe and effective product is especially important for preterm infants.

Development of the gut microbiota is altered in preterm newborns,10 and abnormal colonization is associated with NEC, sepsis and mortality.11,12,13 It is theoretically appealing to prevent or mitigate abnormal microbial colonization of the preterm infant gut with probiotics.14 A Cochrane systematic review and meta-analysis reported that probiotics might reduce the risk of NEC: relative risk (RR) 0.54, 95% confidence interval (CI) 0.45 to 0.65; 54 trials, 10,604 infants; I² = 17%; risk difference (RD) −0.03, 95% CI −0.04 to −0.02; number needed to treat for an additional beneficial outcome (NNTB) 33, 95% CI 25–50.1 This evidence was assessed as low certainty because of limitations in trial design and heterogeneity, and the presence of funnel plot asymmetry suggesting publication bias. Probiotics also might reduce mortality (RR 0.76, 95% CI 0.65–0.89; 51 trials, 10,170 infants; I² = 0%; RD −0.02, 95% CI −0.02 to −0.01; NNTB 50, 95% CI 50–100) and late-onset invasive infections (RR 0.89, 95% CI 0.82 to 0.97; 47 trials, 9762 infants; I² = 19%; RD −0.02, 95% CI −0.03 to −0.01; NNTB 50, 95% CI 33–100).1 Evidence for these outcomes was assessed as moderate certainty. High-quality trials are still needed to confirm efficacy and safety and to identify optimal probiotic formulations and dosing strategies for very preterm infants.

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Authors and Affiliations

  1. Department of Pediatrics, Division of Neonatology, Baylor College of Medicine and Texas Children’s Hospital, Houston, TX, USA

    Mohan Pammi

  2. Department of Pediatrics, Division of Gastroenterology, Hepatology & Nutrition, Baylor College of Medicine and Texas Children’s Hospital, Houston, TX, USA

    Geoffrey A. Preidis

  3. USDA/ARS Children’s Nutrition Research Center, Houston, TX, USA

    Geoffrey A. Preidis

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  1. Mohan Pammi
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Correspondence to Mohan Pammi.

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Pammi, M., Preidis, G.A. How accurate are labels of probiotic products marketed to infants?. Pediatr Res 98, 22–24 (2025). https://doi.org/10.1038/s41390-025-03971-9

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