Daily probiotic supplementation was associated with a lower risk of death and necrotizing enterocolitis in very preterm infants.
Study
The national recommendation for probiotic use in preterm infants was issued in 2020 in Sweden. Following the implementation, probiotic uptake increased from 16.9% in 2020 to an average of 64.8% from 2021 to 2024. The current study also descriptively compared health outcomes between 2017 and 2019 and 2021 to 2024, i.e., the period before and after the national recommendation.
From 2021 to 2024, the rate of the composite outcome of death and necrotizing enterocolitis was lower in infants exposed to probiotics (0.8%) compared to those not receiving probiotics (2.9%). Across the full 2017–2024 cohort, the corresponding rates were 0.8% and 3.4%, respectively, with probiotic supplementation associated with a 72% lower adjusted relative risk of death and/or necrotizing enterocolitis.
When both outcomes were analyzed separately, the findings revealed that the risks of both necrotizing enterocolitis and death were lower in infants exposed to probiotics. The analysis restricted to surgical necrotizing enterocolitis showed an even larger relative risk reduction associated with probiotic supplementation, although there was only one case of surgical necrotizing enterocolitis in the probiotic group compared with 40 in the non-probiotic group.
However, no significant association with the risk of the composite outcome of death and sepsis was observed with probiotic exposure.
To examine the association between probiotic exposure and mortality, a separate analysis was conducted considering necrotizing enterocolitis as a mediator of death. This exploratory analysis suggested that a significant proportion (42.3%) of the observed mortality reduction associated with probiotic exposure was mediated through a lower incidence of necrotizing enterocolitis.
Results and Conclusion
This population-based cohort study reveals that multistrain probiotic supplementation was associated with significantly lower risks of necrotizing enterocolitis and death in very preterm infants. These findings support the broader literature linking probiotic supplementation to a lower risk of mortality and necrotizing enterocolitis in preterm infants.
Notably, the study did not find any association between probiotic exposure and sepsis risk reduction. This finding is consistent with a randomized clinical trial conducted in Australia and New Zealand using the same bacterial strains.
In contrast, a cohort study conducted in England and Wales showed a 6% reduction in sepsis risk among infants receiving probiotics. These inconsistencies in findings may be due to variations in disease definitions, study populations, or probiotic strains used.
During the supplementation period, a survey of Swedish neonatal intensive care units reported no cases of probiotic-associated sepsis, supporting the safety of this strategy. However, the national register did not contain information on the bacteria responsible for sepsis cases. Some risks may still exist, including bacteremia from translocation in high-risk infants and contamination during handling of formulations. These risk factors highlight the need for continuous safety surveillance.
Overall, the study findings support an association between multistrain probiotic supplementation and lower risks of necrotizing enterocolitis and related mortality in very preterm infants, which may help inform shared decision-making between clinicians and families. However, these findings should not be generalized to extremely preterm infants born before 28 weeks of gestation, who typically exhibit much higher baseline risks of adverse outcomes.
The study relied primarily on data collected from the Swedish Neonatal Quality Register, with linked maternal and pregnancy data and validation of mortality data using other national registers. Misclassification of necrotizing enterocolitis cases in the neonatal register may lead to overestimation of the necrotizing enterocolitis incidence. Existing evidence indicates significant differences between register-reported necrotizing enterocolitis cases and medical record reviews.
The authors also disclosed that study author Stefan Johansson is co-founder and chief medical officer of Neobiomics AB, the company listed as the supplier of the probiotic preparation used in the study. The research was funded by the Gastroenterological Research Fund/Swedish Medical Society and the Swedish Research Council, and the authors reported that the funders had no role in the study design, analysis, interpretation, or decision to publish.
Source:
https://www.news-medical.net/news/20260930/Daily-probiotics-help-prevent-severe-gut-disease-in-preterm-babies.aspx