The microbiome is a term used to describe the community of microorganisms that live on or within a host organism. It is increasingly being recognised as in important contributor to human health and disease.
At the MHRA, our microbiome section is focused on understanding how current microbiome therapeutics work, how the microbiome can cause disease, and how we can exploit the microbiome to deliver novel therapeutics. We lead an extensive standardization program, working with the community to generate World Health Organization reference reagents that will harmonise the microbiome field and support reproducibility and good scientific practice.
We are particularly interested in understanding how microbes interact with one another and the human host and have a large anaerobic cultivation facility and strain collection, developing several model systems. We also work closely with MHRA Next Generation Sequencing and bioinformatics colleagues to perform high-throughput sequencing experiments and data analysis; please contact us if you have any questions about our work, would like to collaborate with us, or would like to join one of our large international collaborative studies. If you are a student or postgraduate with your own funding and are interested in undertaking a placement with us, please get in touch, although we cannot guarantee an offer.
Our research projects are primarily funded by Innovate UK, DHSC, MRC, and NIHR. We collaborate with a number of academics, NHS trusts, and industrial partners to deliver state-of-the-art research and reference reagents. All projects listed here are facilitated by productive collaborations across the MHRA divisions of Analytical and Biological Sciences, Vaccines, Diagnostics, and Biotherapeutics.
We are leading one the world’s largest microbiome standardisation program as part of the World Health Organization Biological Standardisation program to develop the first WHO International Reference Reagents for the microbiome. The microbiome field had no accredited or certified reagents to control for biases in experiments prior to this, which has led to a reproducibility crisis across the field.
We are developing DNA and Whole-Cell Standards for analysis of the Gut, Oral Cavity, Respiratory, Skin, and Vaginal microbiomes. To date, we have developed the 1st WHO International Reference Reagents for Gut Microbiome analysis by NGS and the NIBSC Reference Reagent for DNA extractions of gut microbiome samples which is currently undergoing an international collaborative study to be established as the 1st WHO International Reference Reagent for DNA extraction of gut microbiome samples. All developed Reference Reagents are required to undergo an international collaborative study which can require as many as 20 international partners to validate reagents. If you have the capacity to sequence and test our reagents and would like to be part of our International Collaborative studies, then we are interested in hearing from you. Following the development and establishment of these three standards, the program will yield 12 more reference reagents over the next 3 years which will be available from the NIBSC catalogue.
Recognising the need to provide clear guidance for drug developers on how to navigate the regulatory process, and get their innovations to patients safely, we are using funding from BEIS to draft these guidelines. We are working closely with academics, health care professionals, MHRA colleagues, and industry to ensure our guidelines are appropriate to ensure patients have access to therapies that improve their quality of life and deliver benefit with minimal risk.
If you are a medicines developer or manufacturer and would like to contribute to this endeavour, please at firstname.lastname@example.org
Antimicrobial resistance (AMR) is one of the biggest challenges facing us in the 21st century. Reducing our dependency on antibiotics is critical to preserving them. FMT is a therapy which has shown remarkable efficacy at treating antimicrobial-resistant C. difficile infections. Despite this, no known mode of action for FMT is known. We are researching whether FMT can be used to eliminate carriage of multidrug-resistant organisms. We are working with King’s College London and Guy’s and St Thomas’ NHS Trust as part of the FERARO clinical trial looking at the feasibility of giving capsulized FMT to help eradicate AMR. Together we will be performing exploratory research to understand how FMT impacts AMR load in the gut using the standardized metagenomic pipelines developed at MHRA.
Additionally, we are working on new approaches in AMR surveillance by using NGS based AMR screening approaches. We aim to standardise the AMR surveillance field though the introduction of RRs to refine and standardise AMR gene prediction tools for metagenomic data. In turn this will help to increase confidence in AMR surveillance tools mediating a move away from outdated techniques to sequencing-based prediction in order to improve the accuracy and speed of diagnosis.
We work with the MRC Centre for Drug Safety Science at The University of Liverpool to determine whether changes in the microbiome are responsible for adverse reaction events observed during immune checkpoint inhibitor (CPI) therapy for cancer. The microbiome is known to have an immune-regulatory role, and patients are often on therapies before CPI which can disrupt the resident microbiota. Work here could give insights into how to improve CPI efficacy and how to prevent adverse reaction events to CPI.
We also have an interest in colorectal cancer and have recently embarked on a project with UHCW and Warwick University to develop biomarkers for colorectal cancer based on changes in the microbiome. These biomarkers could either be the bacteria themselves or measured as volatile organic compounds which changes in the microbiome can be responsible for.
We have a longstanding collaboration with The University of Warwick and University Hospitals Coventry and Warwickshire researching how the microbiome causes chronic disease in the gut.
Our previous work has identified key microbial imbalances in the gut during Inflammatory Bowel Disease (IBD) and has delineated how location and severity influence microbiome composition during IBD. Currently, we are researching treatments for chronic bowel diseases such as projects investigating how novel probiotics can potentially change the microbiome in patients with Irritable Bowel Syndrome (IBS) and whether Faecal Microbiota Transplantation (FMT) can be used to treat Bile Acid Diarrhoea (formerly termed Bile Acid Malabsorption). These projects focus on the mechanistic role bacteria play in the regulation of host metabolism.
Chrysi Sergaki – Group LeaderSaba Anwar – ScientistEvette Hillman – PhD studentJacob Dehinsilu – PhD studentBlair Merrick – Clinical Research Fellow (based at KCL/Guy’s and St Thomas)