Abstract
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.
Highlights
The initial colonization of the neonatal gut plays a critical role in overall gut microbiota assembly, which can affect gut and systemic health across the lifespan [1]
These findings indicate the strain B. infantis EVC001 can colonize the preterm infant gut in high numbers
Supplementation with B. infantis EVC001 has been shown to increase the abundance of total bifidobacteria, resulting in positive effects including reduced abundance of enterobacteria and decreased signs of enteric inflammation in both term and preterm infants [17, 18, 47]; safety and tolerability of EVC001 in a preterm population had yet to be assessed in a controlled study with prospective adverse event data collection
Summary
The initial colonization of the neonatal gut plays a critical role in overall gut microbiota assembly, which can affect gut and systemic health across the lifespan [1]. Hospitalized preterm infants in the neonatal intensive care unit (NICU) are colonized by potential pathogens found on hospital surfaces [6, 10] and are regularly exposed to medications such as antimicrobials [11]. These circumstances have a profound and detrimental impact on the developing preterm gut microbiome, including a propensity for high-mortality conditions such as necrotizing enterocolitis (NEC) and late onset sepsis [12]. Strategies to stabilize and support overall gut health by increasing populations of beneficial Bifidobacterium in the preterm gut warrant attention
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