It is 27 June and it is World Microbiome Day!

World Microbiome Day celebrates all things microbial, all around the world. It introduces international microbiome researchers to the public to raise awareness of the vibrant and diverse world of microbes and invite the public and industry professionals to share their thoughts and activities with the microbiome community.

Clinical researchers across King’s Health Partners including Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital and King’s College London have been working to find solutions to anti-microbial resistance.

Antimicrobial Resistance (AMR) occurs when bacteria change over time and no longer respond to medicines such as antibiotics making infections harder to treat and increasing the risk of disease spread, severe illness and in severe cases death. (WHO).

Resistance to antibiotics is a growing and serious threat to worldwide health, and means that doctors may be limited in the types of treatments that they can offer to patients. Without effective antibiotics even simple infections could become deadly, making routine medical procedures too dangerous to perform. There is an urgent need to find new antibiotics, but this takes time and is very expensive. There is growing interest in non-antibiotic treatments like Faecal Microbiota Transplant (FMT) to deal with this problem. FMT is the transfer of bacteria from the guts of healthy donors (taken from their poo) into the gut of a patient. The aim is to restore a healthy balance of bacteria (reducing harmful ones and increasing good ones). It is currently used to treat patients with repeated Clostridium difficile infection. FMT is very effective and safe in treating this group of patients, with success rates of over 80%. Initial research shows that it may be helpful in other conditions. Especially for excluding antibiotic resistant bacteria (ARB) found in some patients’ guts.

FERARO study

Dr Simon Goldenberg – a consultant Microbiologist and Infection Control doctor at Guy’s and St Thomas’ and Reader at King’s College London and his team are working on to establish whether restoring the balance of healthy bowel bacteria can help to fight antibiotic resistant bugs through the FERARO study.

The FERARO study will look at whether giving FMT to patients with ARB is an achievable treatment. We will see if it is both safe and acceptable to patients, without side effects. This will allow doctors to treat infections in these patients better. If the treatment works it could be rapidly brought into the NHS. This could help patients who have ARB and can’t be treated with current antibiotics.

Within the study 40 patients with ARB will be randomly chosen to receive FMT (swallowed as tasteless and odourless capsules). Another 40 patients will be randomly chosen to receive identical placebo capsules. Patients will have stool (poo) samples collected before and after FMT. These will be taken at days 10, 40, 100 and 190. We will use these to see what impact the treatment has on their gut bugs. We will also see if the treatment causes any side effects like bad taste, burping, diarrhoea and infection.

The FERARO study is still looking for healthy volunteers to donate their stools to help with production of the study’s FMT capsules. If you are interested in donating a stool sample please contact Blair.Merrick@gstt.nhs.uk.  If you are a patient with ARB interested in taking part in the FERARO study, please speak to your doctor about your suitability to be referred to the study.

To find out more about the FERARO trial please visit https://fundingawards.nihr.ac.uk/award/PB-PG-0418-20007

 

PROMISE trial

Professor Debbie Shawcross, Professor of Hepatology and Chronic Liver Failure at the Institute of Liver Studies at King’s College London and her team are soon to start work on a trial looking to assess the effectiveness of FMT to improve outcomes in patients with cirrhosis through the PROMISE trial.

There is an evolving crisis of chronic liver disease (CLD) in the UK and it is the only major chronic disease which is on the rise. The advanced stages of CLD, known as cirrhosis (a hardening and scarring of the liver), is the third biggest cause of death and loss of working life years behind heart disease and self-harm. People die from cirrhosis young with more than 1 in 10 in their 40s. Patients with cirrhosis are very susceptible to infections, antibiotics become ineffective and patients may become infected with ‘super bugs’. There is an urgent need for antibiotic-free approaches.

There are increased numbers of ‘unfriendly’ bowel bacteria in patients with cirrhosis which emit substances which are harmful to health and disrupt the immune system. The PROMISE trial is looking to establish whether it could be beneficial to replace the unfriendly bowel bacteria in patients with cirrhosis with bacteria donated from a healthy person by performing a type of bowel bacteria transplant (known as faecal microbiota transplantation or FMT).

The team have recently performed a preliminary trial of FMT which was placed into the bowel with the help of a flexible camera (endoscopy). The study showed FMT was safe with no serious side effects, but patients told the team that they would prefer to take tablets rather than have an endoscopy. The team have therefore developed tasteless an odourless capsules which contains dried stool from a healthy donor.

Patient participants in the PROMISE trial will be selected at random to have FMT treatment or placebo, and both the study team and the patients will not know which treatment they are taking. The patients will need to take 5 capsules every 3-months. Patients will continue treatment for a total of 21-months or until they develop their first infection leading to hospital admission and will be followed-up for a maximum of 2-years. The study will also examine if having FMT will reduce the side effects of cirrhosis, and if it has beneficial effects on the liver and immune system. The study team will look at whether it reduces hospital admissions, the incidence of ‘super-bug’ infections and death. Laboratory studies led by Dr Lindsey Edwards, a mucosal immunologist specialising in bacterial infections and antibiotic resistance within Prof Shawcross’ team will look at whether FMT treatment will help the immune system fight infection; thus reducing the need for antibiotic prescription. As patients with chronic liver disease are particularly at risk of developing life-threatening infections and acquiring antibiotic resistance.

To find out more about the PROMISE trial please visit https://fundingawards.nihr.ac.uk/award/NIHR130730

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