1. Infants receiving the probiotic preparation B. infantis EVC001 had a 73% reduction in risk of necrotizing enterocolitis (NEC) in a cohort of about 500 very low birth weight infants.
2. Administration of probiotic was associated with a significantly decreased rate of NEC-associated mortality compared to controls.
Evidence Rating Level: 2 (Good)
Study Rundown: Necrotizing enterocolitis (NEC) is a significant cause of morbidity and mortality in preterm and very low birth weight (VLBW) infants. Past studies have generally indicated that probiotic administration may prevent NEC by countering gut dysbiosis, but there is a lack of consensus on the use, preparation, and timing of probiotics. This study in a single neonatal intensive care unit (NICU) aimed to examine the efficacy of administering a single-strain probiotic, Bifidobacterium infantis EVC001, in preventing incidence and mortality of NEC. NEC was diagnosed in 2.7% of the about 180 treated infants compared to 11% of the 300 infants in the control group. None of the infants in the treated group died of NEC, compared to 2.7% in the untreated cohort. Relative decreases in rates of NEC incidence and mortality were similar in extremely low birth weight (ELBW) infants. No cases of B. infantis bacteremia or other directly attributable complications were observed. Though the use of the gut colonizer B. infantis as part of multi-bacterial strain probiotic preparations has been reported in the past, this is the first study to report the efficacy of this single agent for NEC prevention. Generalizability is limited by the relatively modest size of the cohort, representing only 38 total cases of NEC, and by the variations in both timing and number of probiotic doses in the supplemented group. Additionally, the retrospective cohort design comparing two groups during different time periods places the study at risk for confounding factors influencing the outcomes. However, this study contributes to a strong and growing body of evidence in favor of probiotic supplementation in infants at high risk of NEC.
Relevant Reading: Probiotics and necrotizing enterocolitis
In-Depth [retrospective cohort]: VLBW infants (<1500 g) fed with human milk-based diets and admitted to a single NICU between 2014 and mid-2018 were included in the control group. Infants in the intervention group were admitted to the same NICU between 2018 and 2020 and were treated with at least 2 doses of B. infantis EVC001. Significantly fewer infants in the cohort receiving EVC001 received antenatal steroids and significantly fewer were female. A regression model adjusting for sex, birth weight, gestational age at birth, and mode of delivery yielded a risk ratio of 0.27 for NEC in the EVC001 group compared to the control group (95% confidence interval 0.094-0.614, p<0.01), representing a number needed to treat of 13. In ELBW infants (<1000 g), there was an adjusted risk ratio of 0.28 (0.09-0.70, p=0.02) for NEC incidence.
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