To be 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), the study will be funded by a grant from the Bill & Melinda Gates Foundation.
Recent studies have shown that a combination of prebiotics and probiotics can help to significantly reduce sepsis in infants, and DuPont was selected to provide a comprehensive analysis of the safety and characteristics of its new Lactobacillus plantarum strain of probiotics.
In addition, the company will develop a validated molecular method for the specific detection of the strain, which will help to determine whether or not a precise prebiotic-probiotic combination can effectively colonise the infant microbiome and lower the incidence of sepsis.
A study in two parts
Speaking to NutraIngredients-Asia, global business development leader at DuPont Nutrition & Biosciences (Probiotics), Buffy Stahl, said: "The study will use a unique strain of L. plantarum, which DuPont is manufacturing under its highest quality specifications to be suitable for infant consumption.
“We are following international regulatory guidelines, so the researchers can administer the safest and highest quality probiotics directly through breastmilk or water daily, which will be the delivery format for this study."
The trial will begin in the fourth quarter of the year 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.
Stahl said, "The trial design for both studies will be similar, at least in terms of the primary outcome of looking at sepsis and death in newborn / day-old infants
“In terms of the type of enrolment, the duration and the sample size, this study will be similar to a large trial on sepsis in infants conducted by the University of Nebraska Medical Centre, which assessed 4,556 Indian infants weighing at least 2kg at birth, and monitored them for 60 days."
She believes DuPont’s extensive industry experience and high standards for probiotics make the firm an ‘ideal candidate’ to contribute to this area of research.
The company had previously developed and introduced several methods for strain-specific identification of probiotics, which were then published for non-profit organisations such as the US Pharmacopoeia.
"These methods are well-suited for clinical research on the microbiome, and the researchers behind the study can take advantage of our expertise to specifically identify the unique strain of L. plantarum used in the study."
She explained that DuPont had used genomic comparisons to identify the uniqueness of L. plantarum, which could then be used to identify the same strain in the infant gut when the researchers assessed the trial participants.
This could help to show whether or not this strain had successfully colonised the infant gut, as well as determine how long it would remain there.
At the same time, Stahl emphasised the importance of an assay that could identify the exact strain delivered in the study, in order to eliminate the ‘background noise’ of other varieties of L. plantarum that may occur naturally in the gut.
Colonisation and commercialisation
While DuPont’s primary goal for its new L. plantarum probiotic strain is to ensure it is developed ‘to the highest standards’ to support the clinical trial, its secondary goal is commercialisation of the strain.
To this end, the firm is working on developing branded applications for the strain in both infant formula and oil drops for infants.
Stahl said, "This is a completely new strain that has not been commercialised. We do have other probiotic strains used in our existing infant health offerings, so this will add to our portfolio and expertise in paediatric and infant products that contain probiotics to support immune health."
She also said that apart from reducing the incidence of sepsis, DuPont’s L. plantarum strain could have other health benefits and applications.
"The University of Nebraska trial found (that probiotic supplementation led to) a reduction in the incidence of lower respiratory tract infections and diarrhoea in the children.
“We believe the strain also has positive effects on the development and support of gut health and the immune system."
Affecting an estimated three million newborns and 1.2 million children suffering globally every year, sepsis is a leading cause of newborn deaths, especially in developing countries such as Bangladesh.
DuPont’s collaboration with SickKids supports the UN’s Sustainable Development Goals of ending preventable deaths among newborns, and children below five years old, as well as to lower the incidence of neonatal mortality to 1.2% of live births and under-five child mortality to 2.5% of live births by 2030.