FERARO
Research type
Research Study
Full title
FERARO: A prospective, randomised placebo controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms
IRAS ID
264206
Contact name
Simon D Goldenberg
Contact email
Sponsor organisation
Guy's and St Thomas NHS Foundation Trust
Eudract number
2019-001618-41
ISRCTN Number
ISRCTN34467677
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The gut has trillions of bacteria (bugs) which are important to keep us healthy. These bugs are called the microbiota and are always evolving to beat antibiotics used to fight them (resistance). Resistance is a serious threat 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. 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. It is currently used to treat patients with Clostridium difficile infection. This infection causes severe diarrhoea and stomach pain, normally after having antibiotics which have harmed the microbiota. Initial research shows that it may be helpful in other conditions such as excluding antibiotic resistant bacteria (ARB) found in some patients' guts.
This study looks at whether giving FMT to patients with ARB is an achievable treatment. We will see if it is safe and acceptable. This will allow researchers to carry out a larger clinical trial to see if FMT can reduce or get rid of ARB.
80 patients with ARB will be randomly chosen to receive FMT (swallowed as capsules) or identical capsules without the bugs – a placebo. Patients will be asked to provide stool (poo) samples before and after taking the treatment to measure the impact of treatment on their gut bugs and to monitor any side effects. Patients will be asked to report any side effects after taking the treatment. They will be followed up for 6 months to check how they are feeling and collect stool samples.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0117
Date of REC Opinion
20 Feb 2020
REC opinion
Favourable Opinion