Speaking with us at the recent IPA World Congress + Probiota Americas 2019 event in Vancouver, Canada, Buffy Stahl, global business development leader at DuPont Nutrition & Biosciences (Probiotics), explained that the occurrence of sepsis in infants remains “stubbornly high in developing countries.
“DuPont saw this opportunity where a trial had been run on a Lactobacillus plantarum strain and published in the journal Nature in 2017, which demonstrated a nearly 40% reduction in death occurrence in India,” she added.
“When the Gates Foundation approached us, we were very happy to understand the Lactobacillus plantarum species being a preferred manufacturer of probiotics. We did some genetic testing on the strain and uncovered its full genome sequence and it is quite unique among all the other probiotics on the market.”
The study is being conducted by Canada’s Centre for Global Child Health at The Hospital for Sick Children (SickKids) in conjunction with the International Centre for Diarrhoeal Research and the Child Health Research Foundation (both in Bangladesh), and funded by a grant from the Gates Foundation.
The trial will begin in the fourth quarter of 2019 as the first of two large trials involving probiotic treatment for sepsis in infants. The first will be an initial intervention and observational study, and the second trial — also to be conducted in Bangladesh — will begin in the fourth quarter of 2020.
“It’s a landmark trial,” said Stahl. “I think this will be undoubtedly the largest ever demonstration of clinical efficacy infants to date. It may even be the largest probiotic trial ever conducted.
“In partnership with the Hospital for Sick Children, DuPont will manufacture this specific probiotic ingredient in order to provide the investigational product for this very large trial that will possibly be conducted in up to 8,000 infants in Bangladesh.”
DuPont primary goal is philanthropic – to support the Gates Foundation – but the company is also planning to commercialize the strain in the future.
“The first demonstration in reducing sepsis and death in India gave leading indications that this strain has a little more power even outside developing countries,” said Stahl. “Around infant development, DuPont is looking to commercialize the strain down the road in order to offer that for things like dietary supplements applications, such as infant drops or infant formula addition.”
Sepsis affects an estimated 3 million newborns and 1.2 million older children globally every year. It is a leading cause of newborn deaths, especially in developing countries such as Bangladesh.