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Peer-reviewedCC BY-NC 4.0BMJ Open

Randomised controlled trials of faecal microbiota transplantation in adult inpatients: a scoping review study protocol

  • Kevin M Durr1,2
  • Christine Hum3
  • Taylor Kain4,5,6
  • Alexandre Tran1,3,7
  • Shane English1,3
  • Lauralyn McIntyre1,3
7 affiliations
  1. 1Department of Critical Care, University of Ottawa, The Ottawa Hospital, Ottawa, Ontario, Canada
  2. 2Department of Emergency Medicine, University of Ottawa, The Ottawa Hospital, Ottawa, Ontario, Canada
  3. 3Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  4. 4Department of Critical Care Medicine, The University of Toronto, Toronto, Ontario, Canada
  5. 5The University of Toronto, Toronto, Ontario, Canada
  6. 6University Health Network, Toronto, Ontario, Canada
  7. 7Division of General Surgery, Department of Surgery, University of Ottawa, The Ottawa Hospital, Ottawa, Ontario, Canada
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Abstract

Introduction: Recently, Health Canada and the United States Food and Drug Administration approved the use of Rebyota, a regulated faecal microbiota transplantation (FMT) product for the treatment of recurrent and refractory Clostridium difficile infections. FMT is now being studied for other acute conditions including infectious, autoimmune, metabolic and psychiatric illnesses as these conditions are also associated with significant alterations to the gut microbiota. To summarise the accumulation of this evidence base, we are conducting a scoping review of all adult inpatient randomised controlled trials to describe the populations studied, the type of FMT administered, the outcome measures assessed and the safety profile of FMT.

Methods: This scoping review is designed based on the step-based approach proposed by Arksey and O’Malley, with updates recommended by Peters et al multiple databases will be searched, including Medline, EMBASE and CENTRAL. Selected articles will be limited to those available in English. Two independent reviewers will perform article screening on the Covidence software as well as data abstraction using a pre-piloted Excel data extraction form. Study findings will be presented in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines.

Ethics and dissemination: Given the nature of the scoping review, ethics approval is not required.

Our findings will be disseminated on multiple levels. We aim to present the study results at relevant Canadian and international scientific meetings. We also plan to publish the findings of this review in an open-access medical journal to reach a broad international audience.

Trial registration number: This protocol was registered on Open Science Framework (https://osf.io/nyzwb/overview).

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Cite

BibTeXRIS
BibTeX
@article{durr2026randomised,
  title = {{Randomised controlled trials of faecal microbiota transplantation in adult inpatients: a scoping review study protocol}},
  author = {Kevin M Durr and Christine Hum and Taylor Kain and Alexandre Tran and Shane English and Lauralyn McIntyre},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-122741},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122741},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Randomised controlled trials of faecal microbiota transplantation in adult inpatients: a scoping review study protocol
AU  - Kevin M Durr
AU  - Christine Hum
AU  - Taylor Kain
AU  - Alexandre Tran
AU  - Shane English
AU  - Lauralyn McIntyre
PY  - 2026
DA  - 2026/10/30
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-122741
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-122741
AB  - Introduction: Recently, Health Canada and the United States Food and Drug Administration approved the use of Rebyota, a regulated faecal microbiota transplantation (FMT) product for the treatment of recurrent and refractory Clostridium difficile infections. FMT is now being studied for other acute conditions including infectious, autoimmune, metabolic and psychiatric illnesses as these conditions are also associated with significant alterations to the gut microbiota. To summarise the accumulation of this evidence base, we are conducting a scoping review of all adult inpatient randomised controlled trials to describe the populations studied, the type of FMT administered, the outcome measures assessed and the safety profile of FMT.  Methods: This scoping review is designed based on the step-based approach proposed by Arksey and O’Malley, with updates recommended by Peters et al multiple databases will be searched, including Medline, EMBASE and CENTRAL. Selected articles will be limited to those available in English. Two independent reviewers will perform article screening on the Covidence software as well as data abstraction using a pre-piloted Excel data extraction form. Study findings will be presented in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines.  Ethics and dissemination: Given the nature of the scoping review, ethics approval is not required.  Our findings will be disseminated on multiple levels. We aim to present the study results at relevant Canadian and international scientific meetings. We also plan to publish the findings of this review in an open-access medical journal to reach a broad international audience.  Trial registration number: This protocol was registered on Open Science Framework (https://osf.io/nyzwb/overview).
SN  - 2044-6055
SN  - 2044-6055
ER  -