Persephone Biosciences announces the publication of the largest peer-reviewed US study on its infant synbiotic, revealing safety, gut colonisation, and metabolic enhancements in toddlers, supporting its potential to improve early-life microbiome development.
Persephone Biosciences said a peer-reviewed study of its infant synbiotic has strengthened the clinical case for its microbiome-focused products, after researchers reported results from what the company described as the largest randomised US trial of a Bifidobacterium-based synbiotic in infants and toddlers. The paper appeared in Pediatric Research, the official journal of several paediatric research groups, and the company said it showed the formulation was safe, well tolerated and able to colonise the gut with beneficial bacteria.
The trial enrolled 114 infants and toddlers who were given either the synbiotic or a placebo for four weeks, followed by a two-week observation period. According to the company, the study found that at least one administered strain could still be detected after the washout period in many participants, suggesting the bacteria persisted beyond active supplementation. Persephone also said the intervention increased Bifidobacterium infantis levels and activity linked to the metabolism of human milk oligosaccharides, the sugars in breast milk that help feed certain gut microbes.
The latest publication builds on earlier ARTEMIS readouts. In November, Persephone said topline results from the same trial pointed to safety, colonisation and an improvement in sleep quality among toddlers in the treatment arm. The company has framed the programme as part of a broader effort to support early-life gut health through interventions backed by human studies rather than marketing claims alone.
Stephanie Culler, the company’s chief executive and co-founder, said the findings reflected Persephone’s focus on evidence-led development. Richard Insel, the firm’s chief medical adviser and a co-author of the paper, said studies that measure both safety and microbiome effects remain uncommon in paediatric probiotics. Tanya Altmann, Persephone’s chief paediatric adviser, said the work could help clinicians steer parents towards products with stronger evidence, although the company said further studies are planned to examine possible links with allergy, immunity and other child-health outcomes.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
