Persephone Biosciences Inc., a synthetic biology company reimagining patient and infant health through the development of microbiome-based medicines, today announced that it has enrolled the first subject in its My Baby Biome™ observational study to determine specific biomarkers that are associated with a healthy infant gut.
“We are excited to begin enrollment of our My Baby Biome study as we seek to improve infant gut health outcomes to the benefit of juveniles and adults alike,” said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. “This study – the largest ever conducted to be focused on the infant microbiome – is a significant step in exploring the complex interactions between a child’s microbiome and immediate and eventual health outcomes, including immunology, allergy, overall health and treatment response.”
The My Baby Biome observational study is designed to help define a healthy infant microbiome using real-world data and inform the development of live biotherapeutics, so that eventually all babies can develop a healthy gut microbiome. Parents who register at persephonebiosciences.com/mybabybiome/ will be provided with an easy-to-use collection kit with prepaid shipping to return their newborn’s sample. The nationwide study will then follow participants for seven years after initial testing, with parents asked to complete periodic questionnaires detailing any evolving health issues their child experiences, such as allergies and skin issues.
Research has shown that a baby’s microbiome is integral to its healthy maturity and, if not fully developed, could contribute to multiple suboptimal health outcomes and disease states in later life. Recent studies have revealed that, on average, infants in the US have a low abundance of Bifidobacterium (with the key infant gut strain B. infantis missing in as many as 90% of infants), as well as a high abundance of potentially pathogenic bacteria and a limited capacity to metabolize HMOs from breast milk. The World Health Organization estimates that by 2050, half of the planet’s population will fall victim to at least one allergic disorder.
Persephone was founded by scientists with expertise in microbiology, synthetic biology and genetic engineering, who have a deep knowledge of metabolic systems and the various bacterial strains that make up the human microbiome. The My Baby Biome study will provide a foundation for the company’s infant health programs, including specially formulated probiotics and future initiatives with third party partners.
Stephanie Culler will be appearing on the floor of the New York Stock Exchange at 11:30am ET on Monday, August 8 to announce the launch of the study
The ‘My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)’ study is IRB approved and registered with ClinicalTrials.gov (NCT05472688)