Feeding Activated <i>Bifidobacterium infantis</i> EVC001 to Very Low Birth Weight Infants is Associated with Significant Reduction in Rates of Necrotizing Enterocolitis

Tobias, Joseph; Olyaei, Amy; Laraway, Bryan; Bk, Jordan; Dickinson, Stephanie; Lg, Arroyo; Fialkowski, Elizabeth; Owora, Arthur H.; Scottoline, Brian

doi:10.1101/2021.06.29.21259737

Cited by 3 publications

(2 citation statements)

References 36 publications

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“…The acidified gut milieu is both deterrent to the proliferation of detrimental bacteria including known pathogens ( 4 , 5 ) as well as a deactivator for fecal enzymes implicated in the breakdown of skin, leading to diaper dermatitis ( 52 ). Therefore, the results generated from this study and from previous studies utilizing EVC001 support that this strain provides infants with the capacity to metabolize HMOs with positive results in immune development, as well as decreasing the risk of developing co-morbidities common to prematurity and related to enteric inflammatory conditions, such as NEC ( 51 ). While it is widely accepted that preterm infants benefit from human milk, here we demonstrate the value of matching the right bacteria with diet.…”

Section: Discussionsupporting

confidence: 69%

“…These results are relevant, as recent data suggest metabolites found in the fecal samples of term infants exclusively breastfed and colonized with EVC001 can directly influence the development of the immune system ( 3 ). Furthermore, preterm infants fed EVC001 with a higher representation of genes required to metabolize HMOs in their metagenome (similarly to infants in this study) have significantly reduced signs of chronic enteric inflammation ( 18 ), which may explain why infants receiving EVC001 as standard of care have a significantly lower incidence of NEC and a significantly reduced mortality from NEC ( 51 ). Metabolism of HMOs by B. infantis results in the formation of organic acids, mainly lactic and acetic acids, which lowers the fecal pH.…”

Section: Discussionmentioning

confidence: 58%

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B. infantis EVC001 Is Well-Tolerated and Improves Human Milk Oligosaccharide Utilization in Preterm Infants in the Neonatal Intensive Care Unit

et al. 2022

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Not all infants carry specialized gut microbes, meaning they cannot digest human milk oligosaccharides and therefore do not receive complete benefits from human milk. B. infantis EVC001 is equipped to convert the full array of complex oligosaccharides into compounds usable by the infant, making it an ideal candidate to stabilize gut function and improve nutrition in preterm infants. A prospective, open-label study design was used to evaluate the tolerability of B. infantis EVC001 and its effects on the fecal microbiota in preterm infants in a Neonatal Intensive Care Unit. Thirty preterm infants <1,500 g and/or <33 weeks gestation at birth were divided into two matched groups, and control infants were enrolled and discharged prior to enrolling EVC001 infants to prevent cross-colonization of B. infantis: (1) fifteen control infants received no EVC001, and (2) fifteen infants received once-daily feedings of B. infantis EVC001 (8.0 x 109 CFU) in MCT oil. Clinical information regarding medications, growth, nutrition, gastrointestinal events, diagnoses, and procedures was collected throughout admission. Infant stool samples were collected at baseline, Study Days 14 and 28, and 34-, 36-, and 38-weeks of gestation. Taxonomic composition of the fecal microbiota, functional microbiota analysis, B. infantis, and human milk oligosaccharides (HMOs) in the stool were determined or quantified using 16S rRNA gene sequencing, metagenomic sequencing, qPCR, and mass spectrometry, respectively. No adverse events or tolerability issues related to EVC001 were reported. Control infants had no detectable levels of B. infantis. EVC001 infants achieved high levels of B. infantis (mean = 9.7 Log10 CFU/μg fecal DNA) by Study Day 14, correlating with less fecal HMOs (ρ = −0.83, P < 0.0001), indicating better HMO utilization in the gut. In this study, B. infantis EVC001 was shown to be safe, well-tolerated, and efficient in colonizing the preterm infant gut and able to increase the abundance of bifidobacteria capable of metabolizing HMOs, resulting in significantly improved utilization of human milk.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03939546, identifier: NCT03939546.

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Section: Discussionsupporting

confidence: 69%

Section: Discussionmentioning

confidence: 58%

B. infantis EVC001 Is Well-Tolerated and Improves Human Milk Oligosaccharide Utilization in Preterm Infants in the Neonatal Intensive Care Unit

et al. 2022

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Intravenous Antibiotics in Preterm Infants have a Long-Term Negative Effect upon Microbiome Development Throughout Preterm Life – an observational study

Hutchinson

Costeloe

Wade

et al. 2022

Preprint

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Intestinal dysbiosis is implicated in the origins of necrotising enterocolitis and late-onset sepsis in preterm babies. However, the effect of modulators of bacterial growth (e.g. antibiotics) upon the developing microbiome is not well-characterised. Using high-throughput 16S rRNA gene sequencing combined with contemporaneous clinical data collection, the within-subject relationship between antibiotic administration and microbiome development was assessed, in comparison to preterm infants with minimal antibiotic exposure. During courses of antibiotics, diversity progression fell in comparison to that seen outside periods of antibiotic use (-0.71units/week vs. +0.63units/week, p<0.01); Enterobacteriaceae relative abundance progression conversely rose (+10.6%/week vs. -8.9%/week, p<0.01). After antibiotic cessation, diversity progression remained suppressed (+0.2units/week, p=0.02). Antibiotic use has an acute and longer-lasting impact on the developing preterm intestinal microbiome. This has clinical implications with regard to the contribution of antibiotic use to evolving dysbiosis, and affects the interpretation of existing microbiome studies where this effect modulator is rarely accounted for.

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Bifidobacterium: Host–Microbiome Interaction and Mechanism of Action in Preventing Common Gut-Microbiota-Associated Complications in Preterm Infants: A Narrative Review

Heravi

2023

Nutrients

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The development and health of infants are intertwined with the protective and regulatory functions of different microorganisms in the gut known as the gut microbiota. Preterm infants born with an imbalanced gut microbiota are at substantial risk of several diseases including inflammatory intestinal diseases, necrotizing enterocolitis, late-onset sepsis, neurodevelopmental disorders, and allergies which can potentially persist throughout adulthood. In this review, we have evaluated the role of Bifidobacterium as commonly used probiotics in the development of gut microbiota and prevention of common diseases in preterm infants which is not fully understood yet. The application of Bifidobacterium as a therapeutical approach in the re-programming of the gut microbiota in preterm infants, the mechanisms of host-microbiome interaction, and the mechanism of action of this bacterium have also been investigated, aiming to provide new insights and opportunities in microbiome-targeted interventions in personalized medicine.

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Feeding Activated Bifidobacterium infantis EVC001 to Very Low Birth Weight Infants is Associated with Significant Reduction in Rates of Necrotizing Enterocolitis

Cited by 3 publications

References 36 publications

B. infantis EVC001 Is Well-Tolerated and Improves Human Milk Oligosaccharide Utilization in Preterm Infants in the Neonatal Intensive Care Unit

B. infantis EVC001 Is Well-Tolerated and Improves Human Milk Oligosaccharide Utilization in Preterm Infants in the Neonatal Intensive Care Unit

Intravenous Antibiotics in Preterm Infants have a Long-Term Negative Effect upon Microbiome Development Throughout Preterm Life – an observational study

Bifidobacterium: Host–Microbiome Interaction and Mechanism of Action in Preventing Common Gut-Microbiota-Associated Complications in Preterm Infants: A Narrative Review

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