The products take two forms: a daily synergistic synbiotic for infants aged 0-12 months (the Bloom Formulation) and the Thrive Formulation, for toddlers aged 12-36 months.
Together, they aim to restore beneficial microbes to the gut, reduce the risk of atopic diseases associated with dysbiosis and save the United States billions in healthcare costs.
In this interview, CEO and co-founder Stephanie Culler explains why the first 100 days of a child’s life is integral to future health and how Persephone’s new products aim to provide a solution to an ongoing problem.
NutraIngredients-USA (NIU): How has infant microbiome research evolved over recent years?
Stephanie Culler (SC): For the last decade, there has been extensive research around the world in the infant microbiome space. Microbiome researchers have found that children and babies in Western populations appear to have missing Bifidobacteria, which is a founding member— or keystone—of the gut microbiome.
This is in contrast to what has been observed in developing populations—like the hunters and gatherers of Africa and the old Mennonite population in the United States—where early on in infancy, there’s a high abundance of Bifidobacteria.
A key strain that has been extensively studied in these populations is Bifidobacteria infantis, which is very special in the sense that it has the genetic repertoire to consume all breast milk sugars, or human milk oligosaccharides (HMOs). Other strains of Bifidobacteria have capacity to consume these HMOs but in limited capacity.
This research found that in these traditional populations, infants tended to have high levels of B. infantis—making up around 70% to 80% of their microbiome—but in more ‘modern’ populations, it’s around 8% to 10%. These more traditional populations also had a much lower risk of developing immune-related conditions and atopic diseases like food allergies, eczema, asthma and so on.
Based on this research, we got very interested in understanding this problem and started looking into whether we could develop a product to solve it.
NIU: Is this how the My Baby Biome study came about?
SC: Yes. The My Baby Biome study is one of the largest and most comprehensive studies conducted in the infant microbiome space to date. We had over 700 infants enroll from 48 out of 50 states to map the general population of the U.S. infants.
Looking at their microbiomes, we found that 90% of these babies were missing Bifidobacteria infantis, and the majority of them had some type of Bifidobacteria deficiency.
This is a seven-year study, so we can now see that the children who were missing the Bifidobacteria were more likely to go onto develop these atopic conditions.
We then used AI to ‘crack the infant gut health code’, discovering the three key probiotic species that can put babies back on track. These species are Bifidobacterium infantis, Bifidobacterium longum and Bifidobacterium breve.
We then started work on formulating a product that re-establishes these beneficial bacterial populations, which can promote gut health, aid in immune development and support brain development.
NIU: How do your synbiotics differ from others on the market?
SC: Our synbiotics contain four novel strains of Bifidobacteria, including two strains of Bifidobacteria infantis, human milk oligosaccharides and 100% of the recommended daily value of vitamin D.
We isolated the strains from babies in our own lab—one of the bacterial strains actually comes from my daughter—to create a flavorless powder that easily mixes in with any liquid. And with the two strains of B. infantis, our synbiotics gives the baby’s gut the opportunity to choose which Bifidobacteria works for their niche.
This is a pioneering aspect of our product, as is the fact that we have used strains found in the infant population today. When we looked at other products, we found that many of the current strains of Bifidobacteria on the market were isolated 50 to 70 years ago, but our microbiomes are different now. So the strains used in many products are not what is found in the infant population today—they are vastly genetically different.
Our product is the first to provide fresh, new Bifidobacteria strains that are thriving in babies of today. This is a product for modern babies, and maybe in the next decade, it will need a refresher.
Our synbiotics are also the first to use HMOs that match and feed these specific bacterial strains, rather than using a random prebiotic.
NIU: What is the aim of the ARTEMIS trial?
SC: In order to clinically validate this product and understand how it works in the infant gut, we launched the ARTEMIS trial.
It’s a six-month double-blind placebo-controlled trial, and we are looking to enroll up to 200 participants, including both infants and toddlers. The dosing period will last four weeks and we will collect stool samples before, during and after the intervention.
One of the key challenges we faced was getting approval to evaluate the product in infants. So at first we enrolled toddlers, and then after tolerability was demonstrated, we were able to open it up to infants, and that’s what we’re doing right now.
The study is basically an initial proof of concept to demonstrate a variety of biomarkers. We are essentially looking for colonization of the Bifidobacteria and whether this colonization produces the right metabolites that we know are important for the immune system development.
We will also look at immunological biomarkers to find out what the situation is in the gut—is it inflamed? Does the synbiotic reduce the inflammation? We have observed all of this preclinically, so this study is meant to really validate our preclinical biomarkers.
NIU: Where next?
SC: We will be launching our synbiotics soon, with the aim of getting into Amazon by September and then big retail in 2026.
Following ARTEMIS, we want to launch more clinical studies in partnership with leading clinicians in the infant microbiome space. We are very interested in exploring how antibiotic use impacts the infant and toddler microbiome, for example, because we know that it is associated with risk of atopic disease.
We also intend to launch more products which go beyond the first 1,000 days. We are starting to look at products for older children and parents, as we want mothers to be able to pass on these beneficial bacteria from the beginning.
In the meantime, we want to make moms more aware of just how important these gut bacteria are not only for their health, but for their child’s.
This interview has been edited for clarity and brevity.
