TY - JOUR
T1 - Bifidobacterium longum subsp. infantis EVC001 Administration Is Associated with a Significant Reduction in the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants
AU - Tobias, Joseph
AU - Olyaei, Amy
AU - Laraway, Bryan
AU - Jordan, Brian K.
AU - Dickinson, Stephanie L.
AU - Golzarri-Arroyo, Lilian
AU - Fialkowski, Elizabeth
AU - Owora, Arthur
AU - Scottoline, Brian
N1 - Funding Information:
Supported by grants from Evolve BioSystems , Inc. The study sponsors were involved in initial discussions concerning study design but were not involved in data collection, analysis, or interpretation or in the writing of or decision to submit the manuscript. B.S. serves as a member of the Infant Health Advisory Board of Evolve BioSystems, receiving no compensation for this role. The authors declare no conflicts of interest.
Funding Information:
Supported by grants from Evolve BioSystems, Inc. The study sponsors were involved in initial discussions concerning study design but were not involved in data collection, analysis, or interpretation or in the writing of or decision to submit the manuscript. B.S. serves as a member of the Infant Health Advisory Board of Evolve BioSystems, receiving no compensation for this role. The authors declare no conflicts of interest.A nonconcurrent retrospective cohort design was used to compare clinical outcomes in VLBW infants who did not receive B infantis EVC001 and VLBW infants administered B infantis EVC001 (Evivo; Evolve BioSystems). Study approval was granted by the Oregon Health & Science University (OHSU) Institutional Review Board (IRB 20336).
Publisher Copyright:
© 2022 The Author(s)
PY - 2022/5
Y1 - 2022/5
N2 - Objective: To assess the effects of Bifidobacterium longum subsp. infantis EVC001 (B infantis EVC001) administration on the incidence of necrotizing enterocolitis (NEC) in preterm infants in a single level IV neonatal intensive care unit (NICU). Study design: Nonconcurrent retrospective analysis of 2 cohorts of very low birth weight (VLBW) infants not exposed and exposed to B infantis EVC001 probiotic at Oregon Health & Science University from 2014 to 2020. Outcomes included NEC incidence and NEC-associated mortality, including subgroup analysis of extremely low birth weight (ELBW) infants. Log-binomial regression models were used to compare the incidence and risk of NEC-associated outcomes between the unexposed and exposed cohorts. Results: The cumulative incidence of NEC diagnoses decreased from 11.0% (n = 301) in the no EVC001 (unexposed) cohort to 2.7% (n = 182) in the EVC001 (exposed) cohort (P < .01). The EVC001 cohort had a 73% risk reduction of NEC compared with the no EVC001 cohort (adjusted risk ratio, 0.27; 95% CI, 0.094-0.614; P < .01) resulting in an adjusted number needed to treat of 13 (95% CI, 10.0-23.5) for B infantis EVC001. NEC-associated mortality decreased from 2.7% in the no EVC001 cohort to 0% in the EVC001 cohort (P = .03). There were similar reductions in NEC incidence and risk for ELBW infants (19.2% vs 5.3% [P < .01]; adjusted risk ratio, 0.28; 95% CI, 0.085-0.698 [P = .02]) and mortality (5.6% vs 0%; P < .05) in the 2 cohorts. Conclusions: In this observational study of 483 VLBW infants, B infantis EVC001 administration was associated with significant reductions in the risk of NEC and NEC-related mortality. B infantis EVC001 supplementation may be considered safe and effective for reducing morbidity and mortality in the NICU.
AB - Objective: To assess the effects of Bifidobacterium longum subsp. infantis EVC001 (B infantis EVC001) administration on the incidence of necrotizing enterocolitis (NEC) in preterm infants in a single level IV neonatal intensive care unit (NICU). Study design: Nonconcurrent retrospective analysis of 2 cohorts of very low birth weight (VLBW) infants not exposed and exposed to B infantis EVC001 probiotic at Oregon Health & Science University from 2014 to 2020. Outcomes included NEC incidence and NEC-associated mortality, including subgroup analysis of extremely low birth weight (ELBW) infants. Log-binomial regression models were used to compare the incidence and risk of NEC-associated outcomes between the unexposed and exposed cohorts. Results: The cumulative incidence of NEC diagnoses decreased from 11.0% (n = 301) in the no EVC001 (unexposed) cohort to 2.7% (n = 182) in the EVC001 (exposed) cohort (P < .01). The EVC001 cohort had a 73% risk reduction of NEC compared with the no EVC001 cohort (adjusted risk ratio, 0.27; 95% CI, 0.094-0.614; P < .01) resulting in an adjusted number needed to treat of 13 (95% CI, 10.0-23.5) for B infantis EVC001. NEC-associated mortality decreased from 2.7% in the no EVC001 cohort to 0% in the EVC001 cohort (P = .03). There were similar reductions in NEC incidence and risk for ELBW infants (19.2% vs 5.3% [P < .01]; adjusted risk ratio, 0.28; 95% CI, 0.085-0.698 [P = .02]) and mortality (5.6% vs 0%; P < .05) in the 2 cohorts. Conclusions: In this observational study of 483 VLBW infants, B infantis EVC001 administration was associated with significant reductions in the risk of NEC and NEC-related mortality. B infantis EVC001 supplementation may be considered safe and effective for reducing morbidity and mortality in the NICU.
KW - Bifidobacterium infantis EVC001
KW - NEC
KW - VLBW
KW - dysbiosis
KW - gut microbiome
KW - human milk
KW - necrotizing enterocolitis
KW - neonate
KW - preterm
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U2 - 10.1016/j.jpeds.2021.12.070
DO - 10.1016/j.jpeds.2021.12.070
M3 - Article
C2 - 35032555
AN - SCOPUS:85124561952
VL - 244
SP - 64-71.e2
JO - Journal of Pediatrics
JF - Journal of Pediatrics
SN - 0022-3476
ER -