Evolve BioSystems and KCL in infant gut health collaboration

At the centre of the partnership is the firm’s product Evivo, a probiotic that contains the bacteria Bifidobacterium longum infantis ​that is said to protect the baby from colic, eczema, allergies, diabetes, and obesity.

“Based on our previously published results in infants fed Evivo, we are confident in the ability of our product to restore the natural gut microbiome of babies born by C-section delivery, a life-saving and necessary medical procedure in many cases,”​ said Dr David Kyle, chief scientific officer of Evolve BioSystems.  

“The unintended consequences of C-section delivery on the infant gut microbiome are now becoming apparent, and this is our chance to offset that penalty and improve lifelong health outcomes for millions of babies worldwide,”​ he added.

Babies born via C-section are often accompanied by an incomplete microbiome profile. The presence and numbers of certain microorganisms are transferred to the infant through interactions with the mother’s birth canal. This does not occur in a C-section delivery. 

It is reckoned that the loss of these important gut microbes increases the risk of health problems later in life as critical immune and metabolic programming events are missed during the newborn’s first year.

“We believe that gut dysbiosis may be directly related to the long term health outcomes associated with C-section delivery, including an 18-32% increase in risk for food allergy/atopy/allergic rhinitis/asthma and a 29% increase in risk for inflammatory bowel disease (IBD),”​ said Dr Tracy Shafizadeh, director of scientific communications at Evolve BioSystems.

The PROMESA study​

Researchers from both partners will take part in the PROMESA study (Promotion of a Healthy Gut Microbiome in Elective Caesarean Section Arrivals).

This 2.5 year study will look at the effects of adding Evivo to breast milk with the intention of addressing the gut dysbiosis observed in babies delivered by C-section.

Infants of mothers will be randomised to the B. infantis​ sample group and will receive a daily dose for 28 days. The control group will receive a placebo.

Infant faecal samples/swabs will be collected and stored at regular intervals during the study until 6 months of age and on three follow-up visits until 2 years of age.

“Our principal research question is whether short term daily probiotic supplementation in breastfed infants delivered by Caesarean section will promote a healthy infant faecal microbiome profile that can be maintained by breastfeeding until weaning at 6 months,”​ the study brief states. “The supplement will be added to expressed breast milk once per day.”​

Commenting on the collaboration Dr. Rachel Tribe, reader in women’s health at King’s College London and chief investigator of the PROMESA study said, “We are thrilled at the chance to combine our expertise here at King’s College London, focusing on the role of the maternal microbiome in pregnancy outcome.”​

With funding provided by Evolve BioSystems, the PROMESA study will be conducted by Guy’s and St Thomas’ NHS Trust and King’s College London. Trial subject enrolment is set to begin this month.

Earlier Evivo study​

Evivo’s effectiveness was the subject of a similar study​​ last year in which the product appeared to overcome the problems many commercially available probiotic products have shown to date.

Issues such as a high degree of variability in purity and viability of current probiotic products as well as probiotic trials demonstrating transient colonisation with the administered strain have held back ongoing efforts.

Researchers put this down to a consequence of the ecological and evolutionary adaptations of the probiotic strains used, as stable persistence of an exogenous strain is possible.

The study, conducted at the University of California, Davis Medical Center, found breastfed babies who were given Evivo once a day saw a 79% increase in bifidobacteria compared to a similar group of babies who did not receive Evivo. 

“​Breastfeeding is key to resolving dysbiosis in that it provides the preferred substrate for B. infantis to grow and thrive in the infant gut,”​ explained Dr Shafizadeh.

“B. infantis in turn can inhibit the growth of bacteria associated with dysbiosis. Both the right bacteria (B. infantis) and the right substrate (breastmilk) must be present for this protective intestinal environment to be maintained.” ​

Additionally, these babies also experienced an 80% reduction of groups of potentially harmful bacteria such as E. coli, clostridia, Staphylococcus​ and Streptococcus.​

All babies who had high levels of bifidobacteria​ in the gut were found to have four times lower levels of endotoxin, a compound known to cause inflammation.

“We maintain strict levels of quality control and manufacture Evivo at high levels of GMP to ensure that our product delivers the exact bacterial strain at the labelled dose each and every time,” ​said Dr Shafizadeh.