Clinical Studies: Artemis

Persephone Biosciences ARTEMIS Clinical Study

Persephone Biosciences has launched the ARTEMIS clinical trial (NCT06746285) to study its proprietary infant synergistic synbiotic, a first-of-its-kind combination of four probiotic strains paired with human milk oligosaccharides (HMOs) and Vitamin D. These strains, identified through Persephone’s groundbreaking My Baby Biome study, have never before been given together in a clinical setting.

The ARTEMIS study will enroll up to 200 infants and toddlers (ages 2–24 months), divided into age groups with control arms. Participants will receive a 30-day supply of Persephone’s synbiotic, and researchers will track:

• Changes in gut microbiome colonization

• Shifts in immune profiles

• Evidence of safety and tolerability

This will be the largest clinical trial to date on an infant synbiotic, providing scientific validation in a field where many products lack rigorous testing. The study will include both breastfed and formula-fed babies, and future trials may extend to populations such as C-section delivered infants or those exposed to antibiotics.

Initial data readouts are expected in the first half of 2025, coinciding with the commercial launch of Persephone’s infant synbiotic, with full study results anticipated in 2026.

By advancing clinical research in the infant gut microbiome, ARTEMIS aims to set a new standard for probiotics and synbiotics designed to improve early-life health outcomes.

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