TY - JOUR
T1 - Faecal microbiota transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms (FERARO)
T2 - A prospective, randomised placebo-controlled feasibility trial
AU - Merrick, Blair
AU - Robinson, Emily
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 L.
AU - Goldenberg, Simon D.
N1 - Funding Information:
Acknowledgements ER receives salary support from the NIHR Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College, London
Funding Information:
Funding This independent research is supported by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (grant reference number PB-PG-0418–20007). The funder had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Publisher Copyright:
© © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
PY - 2020/5/25
Y1 - 2020/5/25
N2 - Introduction Antimicrobial resistance 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 beta-lactamase 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 and East Research Ethics Committee (ref 20/LO/0117). Trial results will be published in a peer-reviewed journal and presented at international conferences. Trial registration number ISRCTN registration number 34 467 677 and EudraCT number 2019-001618-41.
AB - Introduction Antimicrobial resistance 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 beta-lactamase 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 and East Research Ethics Committee (ref 20/LO/0117). Trial results will be published in a peer-reviewed journal and presented at international conferences. Trial registration number ISRCTN registration number 34 467 677 and EudraCT number 2019-001618-41.
KW - bacteriology
KW - infection control
KW - microbiology
UR - http://www.scopus.com/inward/record.url?scp=85085412522&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-038847
DO - 10.1136/bmjopen-2020-038847
M3 - Article
C2 - 32457083
AN - SCOPUS:85085412522
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e038847
ER -