Persephone Biosciences Announces Positive Topline Results from ARTEMIS Clinical Trial of First-of-its-kind Synbiotic for Children
- 114 infants and toddlers received Persephone’s synbiotic or placebo -
- The study generated important, positive clinical data on colonization and sleep improvement, after just 30 days of treatment -
- Persephone’s synbiotic, designed to restore critical gut microbes in babies, was launched in September with a waitlist of 10,000 families -
SAN DIEGO, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Persephone Biosciences, a pioneering biotech company focused on unlocking the potential of the microbiome to impact human health, today announced positive topline results from the ARTEMIS study (NCT06746285), a randomized, double-blind, placebo-controlled clinical study of its new, proprietary, synergistic synbiotic (containing two proprietary strains of Bifidobacterium infantis, and one each of Bifidobacterium longum and Bifidobacterium breve, plus human milk oligosaccharides (HMOs) and Vitamin D) for infants and toddlers. Underscoring the company’s rigorous commitment to science, Persephone’s synbiotic was itself created based on the findings from the company’s My Baby Biome1 clinical study.
“Nothing exemplifies our commitment to science-led health solutions more than the fact that we designed, undertook, and have now completed the ARTEMIS study, the largest ever clinical study in the U.S. for a proprietary synbiotic aimed at restoring healthy microbiomes in both infants and toddlers,” said Stephanie Culler PhD, CEO and Co-founder of Persephone Biosciences. “With today’s topline results the ARTEMIS study has demonstrated speedy and robust colonization after just 30 days of treatment – in stark contrast to lactobacillus-based products already on the market - and provided efficacy data in the form of statistically significant improvement in treated toddlers’ quality of sleep.”
“Today’s data is just the beginning. In due course, we naturally plan to share more complete results from this trial at an appropriate scientific meeting or in a publication. As a next step in this scientific journey, we are looking at studying colonization of our synbiotic in children as young as 2-12 weeks (newborns). Because when it comes to creating a healthy microbiome for life, the earlier we can stage a course-correcting intervention, the better.”
The ARTEMIS study enrolled 114 subjects, divided into 2–12-month-old infants (n=58) and 12–24-month-old toddlers (n=56), and included two control (placebo) arms. Subjects who received treatment in each of the two age groups were given a 30-day supply of Persephone’s proprietary infant or toddler synbiotic. Stool samples were collected from subjects before,at two points during, and after synbiotic treatment (or placebo), to determine levels of microbiome colonization, changes to the subjects’ immune profile, as well as to generate evidence of the synbiotic’s safety and tolerability. Charles Baum, M.D. - a gastroenterologist with extensive experience in microbiome-focused clinical studies through his involvement in Persephone’s ongoing ARGONAUT study targeting improved oncology treatment response and prevention - was the study’s principal investigator, with Richard Insel, M.D., Persephone’s Chief Medical Advisor as a co-investigator for the study.
Results:
Demographics
- The ARTEMIS study is the largest ever conducted in the U.S. to evaluate a synbiotic supplement in healthy infants and toddlers.
- The trial enrolled 114 subjects, split between infants (n=58) and toddlers (n=56). In the infant arms, the median age was 5.5 months, with approximately even gender distribution; 76% born by vaginal birth and 98% received breast milk. In the toddler arms, the median age was 17 months, with approximately an even gender distribution, 68% born by vaginal birth and 48% receiving breast milk.
- Subjects were enrolled from a total of 33 U.S. states.
Tolerability
- The tolerability of Persephone’s proprietary synbiotic was validated by the trial – with no statistical difference in adverse events (AEs) during the study period within the two active groups (infants and toddlers) relative to their respective placebo controls, and no increase in average GI-related distress relative to baseline.
Colonization
- Importantly, Persephone’s strains were more prevalent and abundant in toddlers and infants receiving the synbiotic, reflecting successful colonization not observed in placebo controls.
- Moreover, after just 30 days of dosing, at least one strain could be detected in 72% of subjects ages 2-12 months (infants) and 67% of subjects aged 12-24 months (toddlers).
- Following treatment, there was a significant increase in abundance of B. infantis at the species level, as well as in genes associated with human milk oligosaccharides (HMO) utilization in both infants and toddlers treated with Persephone’s synbiotic, but not in the respective placebo arms (p < 0.05).
- In many cases, the presence of the four Persephone strains persisted at 2 weeks after dosing stopped, demonstrating robust colonization of the strains in both infants and toddlers. This is significant when compared to Lactobacillus-based probiotics, which have a lower propensity to colonize the gut.
Sleep Improvement
- In the toddler cohort receiving Persephone’s synbiotic, an improvement in sleep was observed relative to the placebo arm after 30 days (p < 0.05).
“With so many supplements of questionable design and efficacy being marketed to new parents, the ARTEMIS study differentiates and elevates Persephone’s synbiotic by providing parents with compelling tolerability, colonization, and sleep improvement data,” said Richard Insel, M.D., Persephone’s Chief Medical Advisor and Research Professor, University of Rochester School of Medicine & Dentistry, and former Head of Pediatric Health and Wellness at Kenvue (formerly Johnson & Johnson Consumer Health), who is a co-investigator on the study. “The link between the historical collapse of infant and toddler microbiomes and increasing prevalence of allergic disease including eczema, food allergy and asthma is well documented. This positive and encouraging initial data points to the long-term potential of a novel synbiotic like Persephone’s to reverse these worrying but growing trends.”
“It's rare to conduct large scale clinical studies in children outside of infant formula, so Persephone deserves full credit for breaking new ground in the name of child wellness. Additionally, I would be remiss in not noting that this study has been completed in record time – with less than a year from initiation to topline readout,” said Charles Baum, M.D., Principal Investigator for the ARTEMIS study. “Lastly, while this study has focused on the tolerability and efficacy of Persephone’s synbiotic, we are already planning future studies to look at how the product can positively impact other areas of infant health.”
Persephone aims to share the full dataset from the ARTEMIS trial at a future medical meeting.
1 Jarman, J.B., Torres, P.J., Stromberg, S. et al. Bifidobacterium deficit in United States infants drives prevalent gut dysbiosis. Commun Biol 8, 867 (2025). https://doi.org/10.1038/s42003-025-08274-7
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.
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