Publication reports results from the largest U.S. randomized trial evaluating a synergistic Bifidobacterium-HMO synbiotic in infants and toddlers, demonstrating safety, successful gut colonization and biologically meaningful microbiome changes.
Third peer-reviewed publication underscoring the scientific rigor differentiating Persephone’s child health products.
Administered Bifidobacterium strains persisted through the two-week washout period, supporting intestinal colonization beyond active supplementation, unlike transient probiotics such as Lactobacillus.
SAN DIEGO, Aug. 12, 2026 (GLOBE NEWSWIRE) — Persephone Biosciences, a pioneering biotech company focused on unlocking the potential of the microbiome to impact human health, today announced the publication of results from its ARTEMIS clinical trial (NCT06746285) in Pediatric Research, a Nature portfolio journal and the official publication of the American Pediatric Society, the European Society for Paediatric Research and the Society for Pediatric Research. The study represents the largest U.S. randomized clinical trial evaluating a synbiotic in infants and toddlers and demonstrated that Persephone’s proprietary formulation was safe, well tolerated, and successfully colonized the gut with beneficial Bifidobacterium strains.
The article, Safety, tolerability, and gastrointestinal effect of a Bifidobacterium-based synergistic synbiotic in infants and toddlers, is the third peer-reviewed publication emanating from Persephone’s infant and toddler synbiotic program, which comprised the My Baby Biome and ARTEMIS clinical studies. The Company’s previous clinical findings were published in Cell Host & Microbe and Communications Biology. Together, the My Baby Biome and ARTEMIS studies represent one of the most extensively published clinical research programs evaluating infant synbiotics and the developing infant microbiome in the United States.
“The publication of our ARTEMIS study represents another important milestone for Persephone and reflects our commitment to building microbiome interventions supported by rigorous clinical evidence,” said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. “Parents today face hundreds of probiotic options, yet relatively few have been evaluated in randomized clinical trials. We believe scientific validation should define the future of infant microbiome health. These findings further reinforce the scientific foundation of our infant and toddler synbiotic program and the importance of developing products supported by rigorous clinical evidence.”
The trial enrolled 114 infants and toddlers who were randomized to receive either Persephone’s proprietary synbiotic or placebo for four weeks, followed by a two-week observation period with longitudinal microbiome analyses. Stool samples were collected from subjects before, at two points during, and after synbiotic treatment (or placebo), to determine levels of microbiome colonization and for future evaluation of changes to the subjects’ immune profiles.
Key Findings from the Published Study
The published study reported several key findings demonstrating the safety and biological activity of Persephone’s proprietary synbiotic in infants and toddlers:
- Safe and well tolerated. The synbiotic demonstrated a favorable safety and tolerability profile, with no statistically significant differences in adverse events or gastrointestinal symptoms compared with placebo.
- Successfully colonized the infant and toddler gut. After four weeks of supplementation, at least one administered Bifidobacterium strain was detected in 72% of infants and 67% of toddlers and persisted through the two-week washout period, supporting intestinal colonization beyond active supplementation, unlike transient probiotics such as Lactobacillus.
- Demonstrated the intended biological activity. Supplementation significantly increased Bifidobacterium infantis abundance and genes involved in human milk oligosaccharide (HMO) metabolism, consistent with the synbiotic’s intended mechanism of action.
- Reshaped the developing gut microbiome. Colonization of the administered strains was associated with measurable changes in microbial composition and metabolic pathways, providing further insight into how targeted synbiotics influence the developing infant microbiome.
- Observed improvements in toddler sleep. Toddlers receiving the synbiotic experienced a statistically significant improvement in sleep quality compared with placebo, a finding that warrants additional study.
“This publication provides further peer-reviewed evidence that Persephone’s synbiotic is both safe and biologically active in infants and toddlers,” said Dr. Richard Insel, Research Professor of Pediatrics, University of Rochester School of Medicine & Dentistry and Chief Medical Advisor to Persephone Biosciences and co-author of the publication. “Randomized clinical studies that evaluate both safety and microbiome outcomes remain uncommon for pediatric probiotics. ARTEMIS helps address that gap by demonstrating not only safety, but measurable microbiome changes consistent with the intended biological mechanisms.”
Unlike many commercially available probiotics and synbiotics, Persephone’s products are built upon a foundation of human clinical research designed to evaluate safety, tolerability and meaningful health outcomes. The company’s infant and toddler program leverages advanced microbiome science to restore and support the beneficial bacteria that play a critical role in early childhood development.
“Parents frequently ask which probiotic products are actually supported by evidence. Studies like ARTEMIS give pediatricians stronger clinical evidence to help guide those conversations,” said Dr. Tanya Altmann, Chief Pediatric Advisor and Chair of the Medical Advisory Board, Persephone Biosciences. “By strengthening the evidence base, this research helps move the field toward more informed, evidence-based recommendations for families.”
Building on ARTEMIS, Persephone plans to continue advancing its infant and toddler synbiotic program through additional studies evaluating how early microbiome intervention may influence allergic disease, immune development and other pediatric health outcomes.
About Persephone Biosciences
Persephone is a pioneering biotech company reimagining infant and patient health using rigorous clinical research to unlock the potential of the gut microbiome to prevent and treat disease. Persephone is backed by notable investors including Y Combinator, Fifty Years, Susa Ventures, American Cancer Society’s BrightEdge Fund, Pioneer Fund, First Bight Ventures, Propel Bio Partners, Ocampo Capital, Mesa Verde Partners and Capita3. Our My Baby Biome study uncovered the widespread gaps in modern infant gut health. Learn more at www.persephone.bio.
Investor Contact
Laurence Watts
