Persephone Biosciences has enrolled its first subject in the ARTEMIS clinical trial (NCT06746285), marking a significant step forward in pediatric microbiome research. The study will evaluate a novel synbiotic treatment that combines previously untested probiotic strains with human milk oligosaccharides (HMOs) and Vitamin D for infants and toddlers.
The proprietary synbiotic formulation represents a pioneering approach in pediatric gut health, incorporating four validated probiotic strains that have never before been administered in combination. This development stems from insights gained through the company's My Baby Biome clinical study, which was initiated in August 2022.
"Following years of research into the human microbiome, we are delighted both to be closing in on the launch of our groundbreaking infant synbiotic, as well as starting the ARTEMIS clinical trial that will study its effect on the microbiome of both babies and toddlers," said Stephanie Culler PhD, CEO and Co-founder of Persephone Biosciences.
Trial Design and Objectives
The ARTEMIS study will recruit up to 200 participants, stratified into two age groups:
- Infants aged 2-12 months
- Toddlers aged 12-24 months
Participants will receive a 30-day supply of the synbiotic treatment, with control arms included in the study design. The research team will collect stool samples before, during, and after the treatment period to evaluate:
- Microbiome colonization levels
- Changes in immune profiles
- Safety and tolerability of the synbiotic
Comprehensive Assessment Across Feeding Methods
The trial will examine the synbiotic's effects across different feeding scenarios, including both breast-fed and formula-fed infants. Dr. Charles Baum, a gastroenterologist with extensive experience in microbiome research, will serve as the principal investigator. Dr. Baum brings valuable expertise from his involvement in Persephone's ongoing ARGONAUT study, which focuses on improving oncology treatment responses.
"We believe this synergistic combination of probiotics and prebiotics - serving as specific nutrients for these microbes - has the potential to improve infant health," Culler explained. The company envisions future studies exploring the synbiotic's efficacy in specific populations, such as infants born via cesarean section and those who have received antibiotic treatments.
The initiative aims to generate robust scientific evidence for both parents and healthcare providers, potentially establishing a new standard in infant microbiome support. This research could prove particularly significant given the growing understanding of the microbiome's role in early childhood development and long-term health outcomes.
