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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Probiotic use was associated with 51% lower risk for necrotizing enterocolitis in preterm infants. All-cause infant mortality remained stable, but mortality unrelated to necrotizing enterocolitis increased. Routine use of a multistrain probiotic supplement was associated with 51% decline in necrotizing enterocolitis incidence among high-risk preterm infants in two neonatal ICUs, according to results of a retrospective study. Researchers also observed an increase in mortality not associated with necrotizing enterocolitis after probiotic implementation, although all-cause mortality remained unchanged. The causes of these deaths were spread across categories with no plausible link to probiotics and may reflect differences in case mix between the two periods.
Data derived from Imren C, et al. JAMA Netw Open. 2026;doi10.1001\/jamanetworkopen.2026.31601.
Necrotizing enterocolitis is most common among preterm infants, particularly extremely preterm ones born before 28 weeks, according to study background. It is a life-threatening condition associated with microbial imbalance in the gut. Chris H. P. van den Akker \u201c[Necrotizing enterocolitis] remains one of the most feared complications in neonatal intensive care, and its incidence is highest in the most immature infants,\u201d study author Chris H. P. van den Akker, MD, PhD, consultant neonatologist and pediatrician at Emma Children\u2019s Hospital in the Netherlands, told Healio. \u201cRandomized trials and meta-analyses have shown that certain probiotic strains reduce [risk for necrotizing enterocolitis], but uptake in clinical practice has been uneven.\u201d Probiotics as \u2018standard care\u2019 Van den Akker identified two reasons for hesitancy in probiotic uptake: safety concerns stemming from rare cases of probiotic-associated sepsis and difficulty in quantifying probiotic impact, given the varied array of available probiotic formulations. \u201cWe implemented a well-characterized, high-quality three-strain product as standard care in two Dutch level IV NICUs in late 2020 and early 2021, and we wanted to know whether the benefit seen in trials also holds under routine conditions,\u201d he said. \u201cThe question became more pressing after the FDA issued a warning against the use of probiotics in preterm infants in 2023.\u201d Van den Akker and colleagues compared outcomes before and after implementation of the probiotic (ProPrems, Neobiomics) among 1,413 preterm infants (52.5% boys) born between January 2018 and July 2024. All were younger than 30 weeks and\/or weighed less than 1,000 grams. The researchers divided the cohort into preimplementation (n = 598; median gestational age, 27.7 weeks; median birth weight, 950 g) and postimplementation (n = 815; median gestational age, 27.9 weeks; median birth weight, 975 g) groups. The probiotic, given only to the postimplementation group, contained Bifidobacterium infantis Bb-02, Bifidobacterium lactis BB-12 and Streptococcus thermophilus TH-4 and was administered during enteral feeding. Incidence of necrotizing enterocolitis served as the primary outcome. Secondary outcomes included all-cause mortality and mortality not associated with necrotizing enterocolitis. \u2018Closely matched\u2019 real-world, trial results Incidence of necrotizing enterocolitis was higher in the preimplementation group (11.9%) than the postimplementation group (5.3%), with an adjusted risk ratio of 0.49 (95% CI, 0.34-0.7). \u201cThe magnitude of the association closely matched what the randomized trial of this same formulation had reported,\u201d van den Akker said. \u201cThat is not something you can take for granted when moving from trial conditions to routine care, where infants are less selected and protocols are applied less rigidly.\u201d Probiotic implementation also was linked to reduced incidence of medical (aRR = 0.5; 95% CI, 0.26-0.95), surgical (aRR = 0.44; 95% CI, 0.22-0.88) and fatal necrotizing enterocolitis (aRR = 0.47; 95% CI, 0.26-0.86). The association was seen, too, in the subgroup of extremely preterm infants born before 28 weeks (aRR = 0.49; 95% CI, 0.34-0.72). Notably, the researchers observed an increase in mortality not associated with necrotizing enterocolitis after probiotic implementation (aRR = 1.42; 95% CI, 1.01-1.98), although all-cause mortality remained stable (aRR = 1.06; 95% CI, 0.82-1.39). \u201cThis was an unexpected finding at first, but I would caution against overinterpreting it in either direction,\u201d van den Akker said. \u201cWhen we examined the causes of those deaths, they were distributed across several categories with no plausible biological link to probiotic administration, including persistent pulmonary hypertension of the newborn, perinatal asphyxia, and cardiac and neurological causes.\u201d One infant developed probiotic-associated sepsis, the researchers reported. \u201c[Probiotic] implementation should be paired with ongoing outcome monitoring, including for rare adverse events,\u201d van den Akker said. \u201cOne case of probiotic-associated sepsis occurred among more than 800 exposed infants in our cohort.\u201d He acknowledged that the risk is rare, but not nonexistent, and advised clinicians to be familiar with signs of probiotic-associated sepsis to facilitate early intervention. Van den Akker noted that harmonization in probiotic use should be a key focus of future research. \u201cStudies continue to use different strains, combinations and doses, which makes pooled estimates difficult to interpret and slows clinical adoption,\u201d he told Healio. \u201cWe need strain-specific evidence, rather than evidence about probiotics as a category.\u201d For more information: Chris H. P. van den Akker, MD, PhD, was first author of the 2020 ESPGHAN position paper on probiotics in preterm infants and of a subsequent ESPGHAN\/EFCNI statement responding to the FDA warning. He can be reached at c.h.vandenakker@amsterdamumc.nl. Published by: Ask a clinical question and tap into Healio AI’s knowledge base.
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