A study published recently in Frontiers in Pediatrics shows B. infantis EVC001 is well-tolerated and improves human milk oligosaccharide utilization in preterm infants in the neonatal intensive care unit.

Not all infants carry specialized gut microbes such as Bifidobacterium infantis (B. infantis), meaning they cannot fully digest human milk oligosaccharides (HMOs), an important constituent of human milk. In fact, according to one analysis of samples taken from across the United States, more than 90% of infants studied were not seeded with B. infantis1. Research has shown that B. infantis EVC001 converts the full array of HMOs in human milk 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 was conducted at one of the most technologically advanced NICUs in the nation, to evaluate the tolerability of B. infantis EVC001 and its effects on the fecal microbiota in preterm infants in the NICU.

“This study clearly establishes the tolerability of activated B. infantis EVC001 in preterm infants,” said Dr. Sarah Bajorek, DO, neonatologist and co-lead author of the study. “There is so much upside to activated B. infantis EVC001 effectively populating the infant intestine, as it can potentially outcompete pathogenic bacteria and improve the health of infants.”

The study followed 30 preterm infants (<1500 grams and/or <33 weeks gestation at birth), divided into two matched groups. 15 control infants received no EVC001 and 15 infants received once-daily feedings of B. infantis EVC001 (8.0 x 109 CFU) in MCT oil. Control infants were discharged before enrollment of EVC001 group to reduce cross-colonization. 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 to assess the taxonomic composition of the fecal microbiota, functional microbiota analysis, B. infantis, and excretion of human milk oligosaccharides (HMOs).

Researchers found no adverse events or tolerability issues related to EVC001. Moreover, control infants had no detectable levels of B. infantis, while EVC001 infants achieved high levels of B. infantis by Study Day 14, correlating with fewer fecal HMOs, indicating better HMO utilization in the gut. To conclude, B. infantis EVC001 was shown to be safe, well-tolerated, and efficient in colonizing the preterm infant gut, able to increase the abundance of bifidobacteria that metabolizes HMOs, resulting in significantly improved utilization of human milk.

“This study further builds strain-specific evidence regarding the safety and tolerability of activated B. infantis EVC001,” said Rebbeca Duar, PhD, co-lead author of the study and Principal Scientist at Evolve BioSystems. “This study is a positive step in setting the stage for future research into the potential health benefits of the single-strain probiotic B. infantis EVC001 in the hospitalized infant population.”

About Evolve Biosystems, Inc

Evolve BioSystems, Inc. is a privately held leading microbiome company dedicated to discovering and implementing solutions that improve the short and long-term health of infants worldwide. Launched at the University of California, Davis, following more than a decade of pioneering research at the Food for Health Institute, Evolve is a portfolio company of Horizons Ventures, Cargill, Manna Tree Partners, The Bill & Melinda Gates Foundation, and Johnson &Johnson Development Corporation. Since 2014, Evolve has built substantial science and technology assets, focused on the nutrition, biochemistry, physiology of the developing infant gut microbiome. The company’s breakthrough research shows that nine out of ten U.S. infants are suffering from Newborn Gut Deficiency, a dramatic shortage of key good bacteria in the infant gut microbiome. Together with clinical research partners all over the world, Evolve is on a mission to establish B. infantis EVC001 as standard-of-care for all infants – for a better life-long health trajectory.

1. Casaburi et al. Scientific Reports (2021)

Full AMA citation

Casaburi G, Duar RM, Brown H, et al. Metagenomic insights of the infant microbiome community structure and function across multiple sites in the United States [published correction appears in Sci Rep. 2021 May 20;11(1):11050]. Sci Rep. 2021;11(1):1472. Published 2021 Jan 21. doi:10.1038/s41598-020-80583-9.