The initial colonization of the infant gut by microorganisms lays the foundation for a stable adult microbiome. A specific microbial mix is crucial for protecting babies from various infections, supporting immune system maturation, and maintaining overall health. Gut microbial imbalance, or dysbiosis, at infancy increases the risk of long-term health problems.
Stephanie Culler
Cofounder and Chief Executive Officer
Persephone Biosciences
In this Innovation Spotlight, Stephanie Culler, cofounder and chief executive officer of Persephone Biosciences, discusses the initial findings from the ongoing My Baby Biome study, which investigates the gut microbiome of US infants, and the factors contributing to microbial imbalance and related health effects. She also addresses the limitations of traditional therapeutics and highlights the promise of Persephone Biosciences’s next-generation treatments for infant gut health.
Why are children susceptible to gut microbial imbalance, and how does this affect their health?
Many factors can negatively impact infant gut health, including C-section delivery, antibiotic use, and formula use. These impacts are transgenerational, meaning that microbial imbalances in a mother can lead to microbial imbalances in her children. Ultimately, this microbial imbalance means that key microbes are missing during a formative period for gut and immune health. Alarmingly, our My Baby Biome study found that three out of four infants had a microbiome associated with an increased risk of chronic disease.1
Which factors contribute to the gut microbial composition in babies?
Infants are born with a blank slate, but they quickly take on microbes from the world around them, with their mother being their first source. If they are born vaginally, these microbes come from the vagina and gut, whereas if they are born via C-section, they tend to come from the skin. This affects the initial composition of their microbiome. As an infant's microbiome rapidly develops over the first few months of life, they are extremely susceptible to disruptions. Antibiotics and formula use in particular can impact the growth and development of the microbiome. The acquisition of beneficial microbes from siblings and the environment can also positively affect microbiome health.
According to your My Baby Biome study, what are the key gut microbial deficiencies experienced by infants in the US, and how does this affect their health?
Nine out of ten babies are missing a critical gut microbe, Bifidobacterium infantis. This bacterium supports both gut health and immune development and is critical in early life. Additionally, three out of four infants had low levels of Bifidobacterium, which is associated with a higher abundance of potentially harmful gene functions, such as virulence factors, and an increased risk of chronic disease.
Certain gut microbes, including Bifidobacterium infantis, are crucial for infant health, lowering the risk of chronic disease.
iStock, Design Cells
Which therapeutic interventions are commonly used by clinicians to restore an impaired gut microbiome in babies?
To repair the dysbiosis induced by C-section, clinicians are exploring vaginal seeding, fecal seeding, and probiotic use. Seeding means taking a swab from a specific location and then introducing the microbes to the infant, usually orally. Both seeding and probiotic use are intended to introduce microbes that may be missed during C-section birth, but neither has been adopted as a widespread practice yet, as more studies are needed prior to adoption. Past birth, probiotics are the most commonly used intervention for restoring an impaired microbiome. Some physicians suggest probiotic use when a child must take an antibiotic, and formulas are increasingly exploring the addition of probiotics and prebiotics (probiotic foods) in their formulations. Unfortunately, many probiotics are not truly designed for infants, and even when supplemented, infants are not getting the microbes that they are missing. Persephone has built its Synergistic Synbiotic to address this critical issue and push the standard of care.
Based on your ongoing clinical trials, how close are scientists at Persephone Biosciences to developing next-generation probiotics and disease-preventing therapeutics?
At Persephone Biosciences, we are constantly pushing the boundaries of the probiotic space. Our ongoing ARTEMIS clinical study is fully enrolled and will help us better understand the exact impact of our Synergistic Synbiotic in infants and toddlers. Using knowledge from ARTEMIS and other studies like it, we are continuing to innovate not only in infant health, but we are also developing a full pipeline to innovate the field of probiotics.
What is next for Persephone Biosciences?
This September, Persephone Biosciences will commercially launch direct to consumer, its first-in-class synergistic synbiotic for infants and toddlers, designed to restore essential Bifidobacteria missing from modern gut microbiomes.
We are also publishing results from our ARTEMIS clinical trial, which evaluates this synbiotic in infants and toddlers. In parallel, we are preparing to release new findings from our My Baby Biome study.
We are also developing a pipeline of consumer-focused synbiotics that we look forward to commercializing in the future.
- Jarman JB, et al. Bifidobacterium deficit in United States infants drives prevalent gut dysbiosis. Commun Biol. 2025; 8(1):867.
