Pioneering New Study Finds Most U.S. Babies Lack Key Gut Bacteria, Increasing Risk for Allergies and Other Chronic Health Issues

Initial findings published today in Communications Biology - a Nature portfolio journal - show that 76% of infants in the U.S. are deficient in Bifidobacterium, a gut microbiome genus responsible for the utilization of human milk oligosaccharides (HMOs)

SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- Persephone Biosciences, a pioneer in microbiome-based consumer products and therapeutics, today published a new peer-reviewed study in Communications Biology, a Nature portfolio journal, that speaks to the modern epidemic of noncommunicable diseases such as seasonal, food and skin allergies, asthma and other chronic conditions. The publication DOI can be accessed here: 10.1038/s42003-025-08274-7

The My Baby Biome study is one of the largest and most comprehensive investigations of infant microbiomes undertaken in the U.S. to date. Its scale and scientific rigor are supported by a diverse representation of U.S. babies, including race, geography, method of birth, and socioeconomic background. For the past two years, investigators have followed and collected stool samples from over 412 participants aged 4 weeks to 12 weeks. These stool samples were then analyzed to determine microbiome composition and compared over time and against historical data. While the study is planned to run for a total of 7 years, initial findings are already available and bear witness to disturbing trends.

Among its initial findings, the My Baby Biome study has found that 76% of U.S. infant guts had deficient levels of Bifidobacterium. Moreover, 25% of subjects lacked any observable Bifidobacterium altogether. Bifidobacterium are an important bacterium that protects babies from chronic illness and were once a cornerstone of U.S. infants’ microbiome, according to historical data. Over the same period, noncommunicable diseases have increased markedly, making chronic conditions a health crisis of modern times.

“These findings provide strong evidence that today’s infants now lack crucial bacteria once central to healthy microbiome development,” said Stephanie Culler, Ph.D., CEO and Co-founder of Persephone Biosciences. “This loss of key microbes during early childhood development may have long-term consequences for immune health. Our goal is to pioneer clinical studies that seek to expose and understand these microbiome deficiencies where they exist, and then to utilize that data and develop solutions to create better health outcomes.”

“In my over 50 years as a pediatric clinician and researcher, this is one of the most insightful studies I’ve worked on,” said Richard Insel, M.D., Persephone’s Chief Medical Advisor and Research Professor at the University of Rochester School of Medicine & Dentistry, and former Head of Pediatric Health and Wellness at Kenvue (formerly Johnson & Johnson Consumer Health). “The scale and diversity of this cross-sectional study are unparalleled. The results show that disruptions in babies’ gut microbiomes are strongly linked to childhood allergic diseases and point to potential methods to prevent allergic diseases and other chronic inflammatory childhood diseases.”

Persephone Biosciences plans to launch a proprietary infant synbiotic before year-end to support gut and immune health in both babies and toddlers. The synbiotic combines four clinically validated probiotic strains - never before used together – along with human milk oligosaccharides and vitamin D. The synbiotic is currently undergoing confirmatory testing as part of the company’s ARTEMIS trial.

About Persephone Biosciences

Persephone Biosciences is on a mission to unlock the potential of the microbiome to prevent and treat disease. We were co-founded in 2017 by synthetic biologists Stephanie Culler, Ph.D. and Steve Van Dien, Ph.D. Research drives everything we do - from decoding the infant microbiome to developing next-generation probiotics and disease-preventing therapeutics. We have four groundbreaking clinical studies ongoing: ARGONAUT (NCT04638751), My Baby Biome (NCT05472688), ARTEMIS (NCT06746285) and AMBROSIA (NCT06091813). Learn more at www.persephonebiosciences.com, and LinkedIn.

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Elle O’Brien
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