A Dutch retrospective study reveals a 51% reduction in necrotising enterocolitis among very preterm infants after implementation of a specific multistrain probiotic, highlighting the potential for standardised probiotic protocols to improve neonatal outcomes.
Routine use of a multistrain probiotic was linked with a sharp fall in necrotising enterocolitis among very preterm infants in two Dutch neonatal intensive care units, according to a study published in JAMA Network Open and reported by Healio. The retrospective analysis found that the bowel disease developed in 11.9% of infants before the probiotic was introduced, compared with 5.3% afterwards, a difference the researchers said amounted to a 51% lower adjusted risk. The finding adds to a growing body of evidence that carefully selected probiotic strains may help protect the most vulnerable newborns from one of neonatology’s most dangerous complications.
Necrotising enterocolitis is most often seen in babies born very early, especially those delivered before 28 weeks’ gestation, and is linked to disruption in the developing gut microbiome. Chris H. P. van den Akker, a consultant neonatologist and paediatrician at Emma Children’s Hospital in the Netherlands, told Healio that the condition remains one of the most feared problems in neonatal intensive care. He said earlier trials and meta-analyses have already suggested benefit from some probiotic strains, but that use in practice has been inconsistent because of safety concerns and the difficulty of comparing products that differ in strain, dose and quality. The product used in the Dutch units contained Bifidobacterium infantis Bb-02, Bifidobacterium lactis BB-12 and Streptococcus thermophilus TH-4, and was given during enteral feeding.
The study examined 1,413 infants born between January 2018 and July 2024 who were younger than 30 weeks’ gestation and/or weighed less than 1,000 g at birth. Researchers compared outcomes before the probiotic was adopted as standard care and after its introduction. Along with the reduction in necrotising enterocolitis overall, the probiotic was associated with lower rates of medical, surgical and fatal forms of the disease, and the effect was also seen in infants born before 28 weeks. The results were close to those seen in earlier trial data for the same formulation, the authors said, suggesting that the benefit held up outside a tightly controlled study setting.
The investigators did note one important caution: mortality not related to necrotising enterocolitis was higher after implementation, although total mortality did not change. Van den Akker said the deaths were spread across several causes, including persistent pulmonary hypertension of the newborn, birth asphyxia, and cardiac and neurological conditions, with no clear biological reason to blame the probiotic. Only one infant developed probiotic-associated sepsis, underscoring that the risk appears uncommon but not zero. The authors and related reviews say future work should focus on standardising probiotic formulations and dosing, while a separate study in Nature reported that the FDA’s 2023 warning was followed by reduced probiotic use in some high-use centres and a rise in necrotising enterocolitis, highlighting how policy shifts may affect clinical practice.
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