The PROMESA study (Promotion of a Healthy Gut Microbiome in Elective Caesarean Section Arrivals) will investigate the impact of dietary Bifidobacterium longum subsp. infantis EVC001, combined with breastfeeding, in restoring intestinal Bifidobacterium in infants delivered by Caesarean-section, a known cause of infant gut dysbiosis.
"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," says David Kyle, PhD, 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," says Kyle.
B. infantis is an important infant-associated bacterial subspecies that is shown to be passed from mother to infant during vaginal delivery.
Infants born by Caesarean-section are often missing these important beneficial gut bacteria, which participate in critical immune and metabolic programming events during the first year of a newborn's life.
This loss of these important gut microbes is thought to play a role in the increased risk of asthma, allergies and obesity later in life that is well-documented in infants born by Caesarean-section.
"We are thrilled at the chance to combine our expertise here at King's College London, focused on the role of the maternal microbiome in pregnancy outcome, with the expertise of Evolve BioSystems in the infant gut microbiome and probiotic development," comments Dr Rachel Tribe, Reader in Women's Health, in the Department of Women and Children's Health at King's College London and Chief Investigator of the PROMESA study.
The PROMESA study will be conducted by Guy's and St Thomas' NHS Trust and King's College London, funded by Evolve BioSystems.
The double-blind, placebo-controlled clinical trial will begin enrolment this month and participants will be followed for 2 years to evaluate both short and long-term health outcomes following Evivo supplementation.
