By Clinical Research News Staff 

October 2, 2025 | In a food system that prioritizes profits and quantity over nutritional quality, most babies born today lack the gut microbes they need before kindergarten to train their immune system. Persephone Biome, a California-based biotech company, is tackling this issue with its latest product, the Daily Synergistic Synbiotic. The powdered dietary supplement is designed for infants and toddlers up to 36 months or age (but individuals of any age can use the product) and is aimed at understanding and restoring missing microbes critical to immune system development in early life. 

Evidence of the Daily Synergistic Synbiotic supplement’s effectiveness derives from two studies. The first one is the ARTEMIS study, a randomized, double-blind, placebo-controlled study involving over 100 infants and toddlers and the largest clinical trial of a synbiotic supplement in US children to date. Currently, the ARTEMIS study is in data evaluation mode. 

The second, the My Baby Biome study, is a seven-year observational effort that has already enrolled more than 400 infants, making it the largest and most diverse clinical study to map infant microbiomes in the country. Using advanced metagenomics and metabolomics, researchers are mapping the infant microbiome across early development. Data collected so far reveal a striking pattern: more than 90% of U.S. infants are deficient in one or more strains of Bifidobacterium, microbes once common in babies but now largely absent due to widespread antibiotic use, C-sections, and modern dietary shifts. 

This absence carries clinical consequences. According to Persephone co-founder and CEO Stephanie Culler, Ph.D., children missing these microbes face a threefold higher risk of developing atopic conditions, such as eczema, asthma, and food allergies. Broader studies have linked deficiencies to obesity and even diabetes, raising the stakes for early intervention. 

Persephone’s clinical insights have translated directly into product design. Data from My Baby Biome indicated that B. infantis—the “superhero” strain uniquely adept at consuming all the prebiotics found in breast milk—was “almost gone” in babies one to three months old. Of the 8% who retained the species, two strains of the B. infantis, B. breve and B. longum, were found, prompting researchers to include both in the synbiotic formula. These two strains help metabolize plant sugars critical for children transitioning to solid foods. 

Persephone’s symbiotic also includes the full daily recommended value of vitamin D for infants, an often overlooked but essential nutrient for immune health. 

Before the end of the year, the supplement will be available for purchase on Amazon and later next year potentially in retail stores, says Culler. The product meets all FDA regulatory standards for dietary supplements, with ingredients deemed “generally recognized as safe” (GRAS). More significantly, Persephone’s research has attracted growing interest from physicians, signaling potential movement toward integration into pediatric practice. 

Persephone is also working on the AMBROSIA study in partnership with Kroger to learn about properly balancing metabolism in the gut and the extraction of nutrients from the diet. The objective is to see if the intervention improves the quality of the participants’ diets, and the study is expected to publish results in the first half of 2026. 

To read the full story written by Deborah Borfitz, head on over to Bio-IT World News.