Speaking to FoodNavigator-USA after joining the line-up at our FOOD FOR KIDS summit in Chicago in November, Evolve Biosystems chairman and chief science officer David Kyle PhD said the ‘generational loss’ of a specific variety of beneficial bacteria (B. infantis) - likely due to multiple factors including formula feeding, c-sections and antibiotic use - could increase kids’ risk of developing a plethora of health problems, from allergies and eczema to type one diabetes and obesity.
While correlation is not causation, we know that children with low levels of B.infantis are more likely to develop allergic and autoimmune conditions and to struggle with their weight, added Dr Kyle.
A spinoff from UC Davis, Evolve Biosystems aims to recolonize the infant microbiome with B.infantis, a probiotic which used to dominate the guts of babies born in developed countries, and still dominates those of babies in developing countries - where allergies and autoimmune disorders are far less prevalent.
The B.infantis crowds out pathogenic bacteria in the gut and has been shown to digest human milk oligosaccharides in breast milk that babies are otherwise incapable of processing, improving gut barrier function, reducing intestinal permeability, and downregulating gut inflammation, explained Dr Kyle, who describes Evivo as the “first and only clinically proven probiotic for babies.”
B infantis supplementation with breast milk restores fecal pH to healthier levels
He added: “We’re still amazed by the magnitude of the discovery of this symbiotic relationship between B.infantis and these components in breast milk…
“B infantis converts the human oligosaccharides in breast milk into short chain fatty acids that lower the pH of the infant microbiome down to where it used to be in the US 100 years ago, or what you might find in the developing world today.
“In March, the publication of a study showing the increase in infant stool pH over the last 90 years [from around 5.0 in 1926 to 6+ today, which the authors attributed to a loss of B.infantis and an increase in potentially harmful bacteria in the infant gut] had a big impact, because it is something that has really gone unnoticed.”
B infantis is passed from mother to baby during vaginal birth through fecal/oral transfer (Moms poop during birth), explaining why babies delivered via c-section are not exposed. Meanwhile, breastmilk contains human milk oligosaccharides (prebiotics) that provide food for the B infantis in the baby’s gut and help it flourish, explaining why the gut microbiome of formula-fed babies are also less likely to contain B infantis, says Evolve Biosystems.
However, even breastfed babies delivered vaginally may still have low/zero levels of B infantis today because their Moms may have undergone multiple courses of antibiotics in their lifetime such that they no longer have any B infantis to pass on, says CSO David Kyle PhD.
“The discovery of the link between B infantis and the oligosaccharides in human breast milk has been profound. That combination creates what we call the ‘natural microbiome’ in babies, which is not what you find in the vast majority of babies born today.”
In a recent clinical trial, Evolve showed that supplementation with activated B. infantis, along with consumption of breast milk, led to a 79% increase in total bifidobacteria, persisting more than 30 days beyond supplementation; an 80% reduction in potentially harmful bacteria such as E. coli and clostridia; and a reduction in endotoxin, previously linked to type-1 diabetes, allergies and atopic dermatitis.
It also stimulated the production of short chain fatty acids which can reduce the risk of obesity; and lowered infant fecal pH to levels last seen over 100 years ago, added Dr Kyle, who is now developing a simple diagnostic test enabling health professionals to rapidly check babies’ fecal pH levels.
He added: “We also found that antibiotic resistance gene carriage in babies supplemented with Evivo was down 90%, so the antibiotic resistance genes were kind of disappearing, or a better way of looking at it is saying that our poor dysbiotic babies born today have a load of antibiotic resistance genes that is 10 times higher than it should be.”
There is a six times higher incidence of allergies in children with lower levels of bifidobacteria, six times higher incidence of type 1 diabetes in children with lower levels of bifidobacteria, and a trend toward unhealthy body weight in children who had lower levels of bifidobacteria during infancy, according to Evolve Biosystems. Click HERE.
More than 5,000 babies are now consuming EvolveBio’s Evivo activated B. infantis said Dr Kyle, who started selling the product on the Evivo website, Jet.com and Amazon.com a year ago and has recently persuaded a glittering array of investors* from the Bill & Melinda Gates Foundation and Horizons Ventures to Johnson & Johnson Innovation to part with $40m (series C) to fuel Evolve’s global ambitions.
“We’re targeting Moms through social media but we’re also targeting healthcare professionals such as neonatologists and pediatricians who want to see the clinical trials we’ve done so that they can really trust what we are saying. We’ve also announced a partnership with Kings College London in February to study the effects of Evivo, combined with breastfeeding, in restoring B.infantis in around 70 babies delivered by c-section.”
The powdered live bacteria is shipped in refrigerated sachets (that can be stored frozen) that breastfeeding Moms can mix with breastmilk and give to babies via a dropper in the critical first weeks after a baby is born, when the immune system is developing, and good and bad bacteria are competing for space in the infant gut, he said.
“If you have this daily for the first three months with breastmilk you are probably 80% of the way to success.”
A similar product suspended in MCT oil that can be delivered via nasal gastric tubes has also been launched for health professionals to administer in hospital settings for babies that can’t go home immediately after birth.
According to Evolve Biosystems, the generational loss of bifidobacteria colonization in the infant gut "may be explained in large part by modern medical and dietary practices used in industrialized countries," including:
- More c-sections: Infants acquire bifidobacteria from their mothers during vaginal delivery. Since 1970, C-sections have increased from 1 in 20 to 1 in 3 in the US.
- More formula feeding: An important type of bifidobacteria, B. infantis, is uniquely suited to metabolize the carbs in breast milk, but only 50% of infants in the US are fed breast milk at 6 months.
- Increased antibiotic use
Short and long-term effects
While Moms reviewing Evivo have cited multiple immediate benefits in their infants from reduced colic and eczema to better sleep and fewer and better formed stools, Evivo is not therapeutic, and these anecdotal claims are not supported by clinical data, stressed Dr Kyle.
But what about the long-term effects. Can Evolve prove babies consuming Evivo with breastmilk are less likely to develop asthma, diabetes, or obesity?
Right now, this is clearly not possible, and Evolve is not making any long-term promises about disease risk reduction, he said: “We won’t know what the outcomes are for 10-15 years.”
However, retrospective studies such as Vatanen et al, Cell, 2016, which followed gut microbiome development from birth until age three in 222 infants in Northern Europe have made a connection between low levels of bifidobacteria in infants and early-onset autoimmune diseases, which were far more common in Finland and Estonia than in Russia, where kids had higher levels of bifidobacteria, he said.
*Evolve’s $40m Series C funding round was co-led by the Bill & Melinda Gates Foundation and Horizons Ventures, the venture division of the Li Ka Shing Foundation. They were joined by new investors Johnson & Johnson Innovation – JJDC, Inc., Arla Foods, and Continental Grain Company; and early investors Tate & Lyle Ventures, Alta Ventures, MLS Capital, Acre Ventures, and Bow Capital.
Evolve and the Gates Foundation will further expand their partnership to investigate how Evivo can help infants suffering from severe acute malnutrition through the restoration of the gut microbiome.