Study Published in Journal of Pediatrics Discusses Potential for Improved Clinical Care Associated with Administration of B. infantis EVC001 in Very Low Birth Weight Infants
Research published today by Oregon Health & Science University (OHSU) and Indiana University (IU) in the Journal of Pediatrics reports on administering a specific gut bacterium, Bifidobacterium longum infantis EVC001 (B. infantis EVC001) relative to the standard of care for very low birth weight (VLBW) infants in a single Level IV NICU. In this study, researchers retrospectively reviewed medical charts from preterm infants at OHSU from 2014 to 2020. Medical records were used to evaluate adverse events including the incidence of necrotizing enterocolitis (NEC), a devastating inflammatory disease of the infant gut that affects predominantly preterm infants, and NEC-associated mortality. The researchers reported that 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<0.01). Sub-group analysis of extremely low birth weight (ELBW) infants also demonstrated a statistically significant reduction in NEC rates in infants fed EVC001 (n=75) compared to the No EVC001 cohort (n=125). There were no cases of NEC-associated mortality in the EVC001 cohort, which was significant for both the overall EVC001 cohort and the ELBW subgroup.
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Prematurity and very low birth weight is associated with serious gastrointestinal challenges, such as NEC, that adversely affect morbidity and mortality. Of particular concern are those associated with inappropriate development of the infant gut microbiome or bacterial community due to a mismatch between diet and the bacteria present. This can lead to overabundance of potential pathogens, termed gut dysbiosis, and risk of inflammation. In this study, aimed at addressing dysbiosis and risk for NEC through administration of B. infantis EVC001, a strain historically abundant in the gut of human milk fed infants, 483 of 588 infants met the inclusion criteria and were assigned to the No EVC001 human milk-fed cohort (January 2014 - May 2018) and the EVC001 cohort (June 2018 - November 2020) who were fed human milk and at least 2 days of B. infantis EVC001.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<0.01). NEC-associated mortality decreased from 2.7% in the No EVC001 cohort to 0% in the EVC001 cohort (P=0.03).
NICU-based human milk programs are a major step forward in the care of preterm infants, and probiotics are being considered as the next frontier. However, multi-strain probiotic results have been mixed and studies that build support and justification for why to choose specific strains, formulations, regimes and timing will help clarify and advance patient care.
“It is estimated that nearly 1,000 babies in the NICU die from NEC each year in the United States. There is a crucial need to reduce the incidence of NEC; alteration of the infant gut microbiome away from dysbiosis may help limit risks and long-term impacts,” said Brian Scottoline, M.D., Ph.D., Neonatologist, Associate Professor, Pediatrics, Oregon Health & Science University. “We selected B. infantis EVC001 for multiple reasons, including its history as a symbiotic bacterium in human milk fed infants, its ability to extensively metabolize the complex sugars in breast milk that infants cannot digest, and its single strain identity, amongst other aspects. The study is the first to show a significant reduction in NEC incidence using a single strain of bacteria, and the first to demonstrate a significant reduction in NEC in those born with a birth weight of less than two pounds. This result is promising for improving care for the most vulnerable neonatal patients.”
The statistical analysis for this study was conducted in collaboration with Dr. Arthur Owora, Lilian Golzarri-Arroyo and Stephanie Dickinson from the Biostatistics Consulting Center in the Department of Epidemiology and Biostatistics at Indiana University. "This study was the first step in finding an association between B. infantis EVC001 supplementation and reduced NEC rates," said Dr. Arthur Owora, biostatistician from Indiana University School of Public Health Bloomington. "In the future, we hope to expand on these results by performing other clinical trials, including Randomized Controlled Trials (RCTs) as appropriate to further understand the causal link between this important component of a healthy infant gut microbiome and a reduction in NEC cases in preterm infants.”