New Target Product Profile for maternal gut microbiome and nutrition interventions

Burnet Institute and Concept Foundation have partnered to develop a new Target Product Profile (TPP) for maternal microbiome interventions, aiming to improve undernutrition and related maternal, fetal and neonatal outcomes. 

Objective

A Target Product Profile (TPP) is a strategic document that describes the key characteristics (minimum and preferred) that an intervention must address to meet global health needs. TPPs are an important resource for multiple stakeholders in the research and design (R&D) pathway, including funders, researchers, product developers, manufacturers, and regulators.

There is growing interest in the role of the gut microbiome in influencing maternal, fetal and infant health outcomes. An altered gut microbiome in a state of dysbiosis – defined as an “unhealthy imbalance in microbial composition” – is hypothesized to be associated with adverse pregnancy outcomes, possibly via altering the ability of the gut to absorb nutrients. Alterations in maternal microbiome profiles have been associated with a number of adverse pregnancy conditions, including preterm birth, gestational diabetes, hypertension, and early-onset preeclampsia. 

It has been proposed that interventions, such as probiotics or live biotherapeutic products, that can modify or restore the healthy maternal microbiome may be effective at improving maternal, fetal and newborn outcomes.

This Target Product Profile focusses on two types of maternal microbiome interventions: probiotics and live biotherapeutic products (LBPs).

Probiotics

Probiotics are defined as “live microorganisms which when administered in adequate amounts confer a health benefit on the host”. There are many types of probiotics, and these can be either foods or supplements.

Commonly used bacterial genera in probiotics include Lactobacillus, Bifidobacterium, Escherichia, Enterococcus, Bacillus and Streptococcus.

Live Biotherapeutic Products (LBPs)

The FDA defines LBPs as biological products that "1) contains live organisms, such as bacteria; 2) is applicable to the prevention, treatment, or cure of a disease or condition of human beings; and 3) is not a vaccine".

LBPs can consist of either a single or multiple microbial strains, and their functionalities may arise from genetic engineering or through innate processes of the microbes.

Timeline

2023.