Persephone Biosciences’ first consumer product, a daily synergistic synbiotic, is designed to restore beneficial gut microbes that are missing in the majority of infants born in the United States today.
The launch follows earlier NutraIngredients coverage of the company’s My Baby Biome research, which identified a widespread absence of keystone Bifidobacterium species in early life and linked these deficiencies to rising rates of immune-related conditions.
The product release also builds on the company’s presence in the European trade press, with NutraIngredients Europe previously reporting that Persephone was preparing to enter the pediatric supplement space with a clinically driven synbiotic formulation.
Largest U.S. infant microbiome study highlights critical bacterial loss
“The My Baby Biome study revealed that 9 out of 10 infants in the United States were missing key species of Bifidobacterium that play a critical role in early immune system development,” Stephanie Culler, PhD, co-founder and CEO of Persephone Biosciences, told NutraIngredients.
Culler noted that even breastfed, vaginally delivered infants, traditionally considered to have the healthiest microbiomes, often lacked the identified beneficial strains. “Our analyses further demonstrated that Bifidobacterium abundance was associated with reduced prevalence of potentially harmful microbes, including those carrying virulence factors and antibiotic resistance genes,” she said.
The study, published in Communications Biology, also found a strong inverse relationship between Bifidobacterium levels and incidence of allergic disease in the first two years of life.
Targeted strains and HMO pairing drive formulation strategy
Persephone’s Daily Synergistic Synbiotic, which launched earlier this month, includes four proprietary probiotic strains derived from healthy infants: B. infantis PB-01 and PB-02, B. longum PB-03, and B. breve PB-04.
“Infants with the healthiest gut microbiomes in the study consistently carried one of two strains of Bifidobacterium infantis, which were strongly associated with protective immune and metabolic functions,” Culler said.
Each dose also includes 400 IU of vitamin D and a prebiotic blend of four human milk oligosaccharides (2-FL, LNT, 6-SL, and 3-SL), intended to support selective colonization. “These nutrients are the only ones proven to fuel colonization, ensuring the microbes fully establish in the gut to deliver lasting benefits,” Persephone’s press release stated.
According to the company, this pairing of contemporary strains with a defined prebiotic substrate enables the product to “more closely replicate the ecological conditions of the breastfed infant microbiome.”
Industry-first safety certification and clinical validation
The formulation was tested in ARTEMIS, a randomized, double-blind, placebo-controlled study described by the company as the “largest infant/toddler microbiome trial of its kind in the U.S.”
It is also the first and only synbiotic to be certified under the Clean Label Project’s First 1000 Days Promise, which enforces strict limits on contaminants, heavy metals, and allergens in products designed for early life stages. “Every batch [is] tested at Eurofins for heavy metals, allergens, and contaminants,” the press release stated.
Culler added, “It’s a quality product, based on science, that I’ve been giving to my own child.”
Pediatric channel and consumer education rollout
Persephone’s go-to-market strategy includes both direct-to-consumer and pediatric practitioner channels. “This month we will be attending the American Academy of Pediatrics meeting to share our research and engage directly with the pediatric community,” Culler said.
The company is working with both practicing clinicians and academic researchers and will launch a national sampling program in 2026 to provide pediatric offices with access to the synbiotic. “This dual approach allows us to both inform day-to-day clinical practice and build a stronger evidence base through research collaboration,” she said.
Beyond clinical outreach, the brand is building a consumer education platform to support first-time buyers. “Parents deserve more than just a product, so we’re building real support alongside it,” Persephone’s press release stated, citing microbiome workshops and pediatrician communication tools as part of the strategy.
