USA: In a recent trial of 483 very low birth weight (VLBW) newborns, Joseph Tobias and colleagues discovered that B. infantis EVC001 treatment was linked with a substantial decrease in the risk of necrotizing enterocolitis (NEC) and NEC-related death. The findings of this study were published in the Journal of Pediatrics on 12th January 2022.
Preterm, VLBW newborns are disproportionately affected by NEC. In the United States, NEC affects 5-10% of VLBW newborns and has a 23.5 percent overall death rate, while mortality can exceed 50% in extremely low birth weight (ELBW) children who require surgery. This study was conducted with the objective to see how Bifidobacterium infantis EVC001 affected the preterm infants in a single Level IV NICU incidence of NEC.
For this study, from 2014 to 2020, Oregon Health & Science University conducted a non-concurrent retrospective examination of two cohorts of VLBW babies who were not exposed and were exposed to the B. infantis EVC001 probiotic. NEC incidence and NEC-associated mortality were studied, as well as a subgroup study of ELBW newborns. To examine the incidence and risk of NEC-related outcomes in unexposed and exposed groups, log-binomial regression models were utilized.
The key findings of this study were as follow:
1. The cumulative incidence of NEC diagnoses fell from 11.0 % (n=301) in the No EVC001 (unexposed) group to 2.7 % (n=182) in the EVC001 (exposed) cohort (P0.01).
2. When compared to the No EVC001 cohort, the EVC001 cohort exhibited a 73% risk reduction of NEC (adjusted risk ratio 0.27, 95% CI 0.094, 0.614, P0.01), leading in an adjusted number required to treat (NNT) of 13 for B. infantis EVC001.
3. NEC-related mortality fell from 2.7% in the No EVC001 group to 0% in the EVC001 cohort. There was a comparable decrease in NEC incidence, risk for ELBWs, and death (5.6% vs. 0%).
In conclusion, based on these findings, administration of B. infantis EVC001 can be deemed a safe and effective strategy for avoiding NEC in the NICU and changing dysbiosis, which is known to underlay a major proportion of NEC.
Reference:
Joseph Tobias, Amy Olyaei, Bryan Laraway, Brian K. Jordan, Stephanie L. Dickinson, Lilian Golzarri-Arroyo, Elizabeth Fialkowski, Arthur Owora, Brian Scottoline, Bifidobacterium infantis EVC001 Administration Is Associated With a Significant Reduction In Incidence of Necrotizing Enterocolitis In Very Low Birth Weight Infants, The Journal of Pediatrics, https://doi.org/10.1016/j.jpeds.2021.12.070.