Protocol: A prospective, randomised placebo-controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO)

TY - JOUR

T1 - Protocol: A prospective, randomised placebo-controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO)

AU - Merrick, Blair

AU - Robinson, Emily J.

AU - Bunce, Catey

AU - Allen, Liz

AU - Bisnauthsing, Karen

AU - Izundu, Chi Chi

AU - Bell, Jordana

AU - Amos, Gregory

AU - Shankar-Hari, Manu

AU - Goodman, Anna

AU - Shawcross, Debbie

AU - Goldenberg, Simon

PY - 2020/4/3

Y1 - 2020/4/3

N2 - Introduction: antimicrobial resistance (AMR) is rising, largely due to the indiscriminate use of antimicrobials. The human gut is the largest reservoir of antibiotic resistant bacteria (ARB). Individuals colonised with ARB have the potential to spread these organisms both in the community and hospital settings. Infections with ARB such as extended spectrum betalactamase producing enterobacteriales (ESBL-E) and carbapenemase producing enterobacteriales (CPE) are more difficult to treat and are associated with an increased morbidity and mortality. Presently there is no effective decolonisation strategy for these ARB. Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach. Methods and analysis: prospective, randomised, patient-blinded, placebo-controlled feasibility trial of FMT to eradicate gastrointestinal carriage of ARB. Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage will be randomised 1:1 to receive encapsulated FMT or placebo. The primary outcome measure is consent rate (as a proportion of patients who fulfil inclusion/ exclusion criteria); this will be used to determine if a substantive trial is feasible. Participants will be followed up at 1 week, 1 month, 3 months and 6 months and monitored for adverse events as well as gastrointestinal carriage rates of ARB after intervention. Ethics and dissemination: research ethics approval was obtained by London - City & East Research Ethics Committee (ref 20/LO/0117). Trial results will be published in a peerreviewed journal and presented at international conferences. Trial registration number: ISRCTN registration number 34467677 and EudraCT number 2019-001618-41 protocol version 1.1. (dated 23/02/2020)

AB - Introduction: antimicrobial resistance (AMR) is rising, largely due to the indiscriminate use of antimicrobials. The human gut is the largest reservoir of antibiotic resistant bacteria (ARB). Individuals colonised with ARB have the potential to spread these organisms both in the community and hospital settings. Infections with ARB such as extended spectrum betalactamase producing enterobacteriales (ESBL-E) and carbapenemase producing enterobacteriales (CPE) are more difficult to treat and are associated with an increased morbidity and mortality. Presently there is no effective decolonisation strategy for these ARB. Faecal microbiota transplant (FMT) has emerged as a potential strategy for decolonisation of ARB from the human gut, however there is significant uncertainty about the feasibility, effectiveness and safety of using this approach. Methods and analysis: prospective, randomised, patient-blinded, placebo-controlled feasibility trial of FMT to eradicate gastrointestinal carriage of ARB. Eighty patients with a recent history of invasive infection secondary to ESBL-E or CPE and persistent gastrointestinal carriage will be randomised 1:1 to receive encapsulated FMT or placebo. The primary outcome measure is consent rate (as a proportion of patients who fulfil inclusion/ exclusion criteria); this will be used to determine if a substantive trial is feasible. Participants will be followed up at 1 week, 1 month, 3 months and 6 months and monitored for adverse events as well as gastrointestinal carriage rates of ARB after intervention. Ethics and dissemination: research ethics approval was obtained by London - City & East Research Ethics Committee (ref 20/LO/0117). Trial results will be published in a peerreviewed journal and presented at international conferences. Trial registration number: ISRCTN registration number 34467677 and EudraCT number 2019-001618-41 protocol version 1.1. (dated 23/02/2020)

M3 - Article

SN - 2044-6055

JO - BMJ Open

JF - BMJ Open

ER -