Scientists at NIBSC have been awarded over £290,000 to understand the elements of successful treatment of recurrent gut infections and deliver tools that support manufacturers to develop new therapeutic products. The funding is provided by the Department of Health and Social Care as part of the Small Business Research Initiative, or SBRI and managed by Innovate UK.
Changes in the bacteria that live within our guts are increasingly being associated with a range of diseases, from infection to colorectal cancer. Treatments that help to restore the delicate balance of our gut microbiome such as Faecal Microbiota Transplantation (FMT) are therefore being investigated as alternatives to antibiotics for gut infections caused by bacteria like Clostridium difficile (CDI).
As you might have already guessed, FMT involves the transfer of faecal material, and all the microbes within it, from one person’s gut into someone else. Clinical studies have shown FMT can be up to 90% effective in treating CDI infections. However, despite this promise FMT is not widely used mainly due to concerns with its regulation, safety and reproducibility.
In this 12-month project NIBSC will use its world-leading expertise in biological standards to produce three reference standards aimed at improving confidence in FMT treatment. This includes a gut-specific DNA standard to support next-generation sequencing (NGS) technologies and bioinformatics, a gut-specific strain standard to assure the quality of microbiome sample processing and a reference FMT material that provides a benchmark for successful treatment of recurrent CDI infections.
For the study NIBSC will also collaborate with colleagues at the University of Birmingham, who recently ran the UK’s first CDI FMT clinical trial, using samples from the trial and NGS sequencing to elucidate the active components of successful FMT.
It’s hoped this work will facilitate the comparison of gut microbiome studies and support manufacturers to predict the success of FMT products in the pipeline and assure the quality of products post-licensing.