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University of Birmingham the Use of Faecal Microbiota Transplant As University of Birmingham The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: Mullish, Benjamin H.; Quraishi, Mohammed Nabil; Segal, Jonathan P.; McCune, Victoria L.; Baxter, Melissa; Marsden, Gemma L; Moore, David; Colville, Alaric; Bhala, Neeraj; Iqbal, Tariq H.; Settle, Christopher; Kontkowski, Graziella; Hart, Ailsa L.; Hawkey, Peter M.; Williams, Horace R. T.; Goldenberg, Simon D. DOI: 10.1016/j.jhin.2018.07.037 License: Creative Commons: Attribution-NonCommercial-NoDerivs (CC BY-NC-ND) Document Version Peer reviewed version Citation for published version (Harvard): Mullish, BH, Quraishi, MN, Segal, JP, McCune, VL, Baxter, M, Marsden, GL, Moore, D, Colville, A, Bhala, N, Iqbal, TH, Settle, C, Kontkowski, G, Hart, AL, Hawkey, PM, Williams, HRT & Goldenberg, SD 2018, 'The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines', The Journal of hospital infection, vol. 100, no. Supplement 1, pp. S1-S31. https://doi.org/10.1016/j.jhin.2018.07.037 Link to publication on Research at Birmingham portal General rights Unless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or the copyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposes permitted by law. •Users may freely distribute the URL that is used to identify this publication. •Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of private study or non-commercial research. •User may use extracts from the document in line with the concept of ‘fair dealing’ under the Copyright, Designs and Patents Act 1988 (?) •Users may not further distribute the material nor use it for the purposes of commercial gain. Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document. When citing, please reference the published version. Take down policy While the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive. If you believe that this is the case for this document, please contact [email protected] providing details and we will remove access to the work immediately and investigate. Download date: 03. Oct. 2021 HIS/ BSG FMT Guideline: Main Document. The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines. Benjamin H Mullish*1,2, Mohammed Nabil Quraishi*3, Jonathan Segal*1,4, Victoria L McCune5,6, Melissa Baxter7, Gemma L Marsden8, David Moore9, Alaric Colville7, Neeraj Bhala3,9,10, Tariq H Iqbal3,10, Christopher Settle11, Graziella Kontkowski12, Ailsa L Hart1,4, Peter M Hawkey6, Simon D Goldenberg13,14, Horace RT Williams1,2. 1. Division of Integrative Systems Medicine and Digestive Disease, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK. 2. Departments of Gastroenterology and Hepatology, St Mary’s Hospital, Imperial College Healthcare NHS Trust, Paddington, London, UK. 3. Department of Gastroenterology, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. 4. Inflammatory Bowel Disease Unit, St Mark's Hospital, Harrow, London, UK. 5. Public Health England, Public Health Laboratory Birmingham, Birmingham, UK. 6. Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK. 7. Department of Microbiology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK. 8. Healthcare Infection Society, London, UK. 9. Institute of Applied Health Research, University of Birmingham, Birmingham, UK. 10. Institute of Translational Medicine, University of Birmingham, Edgbaston, Birmingham, UK. 11. Department of Microbiology, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK. 12. C diff Support, UK. 13. Centre for Clinical Infection and Diagnostics Research, King's College London, London, UK. 14. Department of Microbiology, Guy's and St Thomas' NHS Foundation Trust, London UK. *Joint first authors. Joint senior authors. Corresponding author. 1 HIS/ BSG FMT Guideline: Main Document. Contact via: Dr Horace Williams Department of Gastroenterology 3rd Floor, Salton House St Mary’s Hospital, Imperial College Healthcare NHS Trust London W2 1NY United Kingdom Email: [email protected] “NICE has accredited the process used by the Healthcare Infection Society to produce ‘The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridium difficile infection and other potential indications: joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines’. The NICE accreditation of HIS methodology is valid for 5 years from March 2015. More information on accreditation can be viewed at http://www.nice.org.uk/about/what-we-do/accreditation” 1. Executive summary: Interest in the therapeutic potential of faecal microbiota transplant (FMT) has been increasing globally in recent years, particularly as a result of randomised studies in which it has been used as an intervention. The main focus of these studies has been the treatment of recurrent or refractory Clostridium difficile infection (CDI) (also referred to as Clostridioides difficile1), but there is also an emerging evidence base regarding potential applications in non-CDI settings. The main clinical stakeholders for the provision and governance of FMT services in the United Kingdom (UK) have tended to be in two major specialty areas: gastroenterology and microbiology/infectious diseases. Whilst the National Institute for Health and Care Excellence (NICE) guidance (2014) for use of FMT for recurrent or refractory CDI has become accepted in the UK, clear evidence-based UK guidelines for FMT have been lacking. This resulted in discussions between the British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS): a joint BSG/HIS FMT working group was established. This guideline document is the culmination of that joint dialogue. 2 HIS/ BSG FMT Guideline: Main Document. 2. Lay summary: Faecal microbiota transplant (FMT) involves the transfer of faeces from a healthy donor to a recipient. There are several different ways to administer the transplant, including endoscopy, enema, nasoenteral tube, or by transferring faecal material into capsules. The transplant may either be administered fresh (i.e. immediately after preparation), or may be prepared in advance, stored in a freezer and thawed when required. FMT is an accepted and effective treatment for recurrent infection by Clostridium difficile, a bacterium which can cause severe illness with diarrhoea, most commonly in frail elderly populations as a complication of antibiotic use. This guideline reviews the evidence for FMT as a treatment for Clostridium difficile infection (CDI) and other conditions. Recommendations are made for: which patients are most likely to benefit, how donors should be selected and screened, how FMT should be prepared and administered, how patients should be followed up, and how FMT services should be configured. 3. Introduction: The aim of the British Society of Gastroenterology (BSG)/Healthcare Infection Society (HIS) faecal microbiota transplant (FMT) working group was to establish a guideline that defined best practice in all aspects of a FMT service, by providing evidence-based recommendations wherever possible, and consensus multi-disciplinary expert opinion where specific evidence is currently lacking. Relevant guidance published to date includes the interventional procedure guidance from the National Institute for Health and Care Excellence (NICE)2, UK and European microbiological guidelines on the treatment of Clostridium difficile infection (CDI)3,4, and recent expert consensus documents on FMT in clinical practice5,6. Furthermore, there have also been national recommendations regarding FMT produced by working groups in several different countries7–9. Principally as a result of randomised studies that have been published in recent years10–17, FMT has become an accepted treatment for recurrent/refractory CDI. The unique remit of this guideline when commissioned by the BSG and HIS was: i. To review the rapidly-growing body of randomised trial evidence for the efficacy of FMT in the treatment of adults (≥18 years), both in CDI and in other clinical conditions, much of which has been published after the publication of current CDI treatment algorithms3,4. 3 HIS/ BSG FMT Guideline: Main Document. ii. To provide specific guidance about best practice for an FMT service within the context of the regulatory framework for the intervention as it currently exists in the UK18,19. The elucidation of the mechanisms underlying the efficacy of FMT in treating CDI remains an active area of global research, with the aim of rationalising FMT from its current crude form to a more targeted, refined therapeutic modality20. Previous research has demonstrated that commensal bacteria cultured from the
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