FERARO

A prospective, randomised placebo controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms

What is this study about?

The human gut has trillions of bacteria (bugs) which are important to keep us healthy. In total these bugs are called the microbiota. The bugs are always evolving to beat antibiotics used to fight them (resistance).

Resistance to antibiotics allows bugs to survive and spread. This 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. This is an infection causing severe diarrhoea and stomach pain, normally after having antibiotics which have harmed the microbiota. 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.

How will this study help people?

This 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.

What will we do in this study?

We will involve patients and members of the public by inviting then to have a say in how the study is designed, performed and reported. 40 patients with ARB will be randomly chosen to receive FMT (swallowed as capsules). Another 40 patients will be randomly chosen to receive identical capsules without the bugs. This is known as a ‘placebo’. 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.

Find out more

You can read the full trial protocol at www.bmjopen.bmj.com/content/10/5/e038847

To find out more about the trial including how to get involved by either donating stool or participating please visit our FAQ page.

This website is supported by the National Institute for Health and Care Research (NIHR), grant no: PB-PG-0418-20007. The views expressed are those of the author(s) and not necessarily those of the NHS, NIHR or the Department of Health and Social Care