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  • ww.sciencedirect.com

    Journal of Hospital Infection 100 (2018) S1eS31

    Available online at w

    Journal of Hospital Infection

    journal homepage: www.elsevier .com/locate/ jhin

    Guidelines

    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) guidelinesq,qq

    Benjamin H. Mullish a,b,y, Mohammed Nabil Quraishi c,y, Jonathan P. Segal a,d,y, Victoria L. McCune e,f, Melissa Baxter g, Gemma L. Marsden h, David Moore i, Alaric Colville g, Neeraj Bhala c, i, j, Tariq H. Iqbal c, j, Christopher Settle k, Graziella Kontkowski l, Ailsa L. Hart a,d, Peter M. Hawkey f, Horace RT Williams a,b,○, Simon D. Goldenbergm,n,*,○

    aDivision of Integrative Systems Medicine and Digestive Disease, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK bDepartments of Gastroenterology and Hepatology, St Mary’s Hospital, Imperial College Healthcare NHS Trust, Paddington, London, UK cDepartment of Gastroenterology, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK d Inflammatory Bowel Disease Unit, St Mark’s Hospital, Harrow, London, UK e Public Health England, Public Health Laboratory Birmingham, Birmingham, UK f Institute of Microbiology and Infection, University of Birmingham, Birmingham, UK gDepartment of Microbiology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK hHealthcare Infection Society, London, UK i Institute of Applied Health Research, University of Birmingham, Birmingham, UK j Institute of Translational Medicine, University of Birmingham, Edgbaston, Birmingham, UK kDepartment of Microbiology, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK lC diff Support, UK mCentre for Clinical Infection and Diagnostics Research, King’s College London, London, UK nDepartment of Microbiology, Guy’s and St Thomas’ NHS Foundation Trust, London UK

    q “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”. qq Versions of this Guideline are published simultaneously in The Journal of Hospital Infection and Gut. https://doi.org/10.1136/gutjnl-2018- 316818. The Editors of the Journals have agreed that joint publication of the article is justified to ensure dissemination of the guidance to all relevant healthcare professionals. * Corresponding author. Address: Department of Microbiology, St Thomas’ Hospital, Guy’s and St Thomas’ NHS Foundation Trust, Westminster

    Bridge Road, London, SE1 7EH, United Kingdom. E-mail address: simon.goldenberg@gstt.nhs.uk (S.D. Goldenberg).

    y Joint first authors. ○ Joint senior authors.

    https://doi.org/10.1016/j.jhin.2018.07.037 0195-6701/ª 2018 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

    http://www.nice.org.uk/about/what-we-do/accreditation https://doi.org/10.1136/gutjnl-2018-316818 https://doi.org/10.1136/gutjnl-2018-316818 mailto:simon.goldenberg@gstt.nhs.uk www.sciencedirect.com/science/journal/01956701 http://www.elsevier.com/locate/jhin https://doi.org/10.1016/j.jhin.2018.07.037 https://doi.org/10.1016/j.jhin.2018.07.037 https://doi.org/10.1016/j.jhin.2018.07.037 http://crossmark.crossref.org/dialog/?doi=10.1016/j.jhin.2018.07.037&domain=pdf

  • B.H. Mullish et al. / Journal of Hospital Infection 100 (2018) S1eS31S2

    A R T I C L E I N F O

    Article history: Received 2 July 2018 Accepted 23 July 2018

    Keywords: microbiota faecal transplant Clostridium difficile inflammatory bowel disease

    about 25% of patients, and some may suffer multiple recurrences.

    evidence-based recommendations wherever possible, and consensus multi-disciplinary expert opinion where specific

    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), but there is also an emerging evi- dence base regarding potential applications in non-CDI set- tings. The key 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. While 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 guide- lines for FMT have been lacking. This resulted in discussions between the British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS), and a joint BSG/HIS FMT working group was established. This guideline document is the culmination of that joint dialogue.

    Lay summary

    Faecal microbiota transplant (FMT) involves the transfer of a sample of faeces from a healthy donor to a recipient. There are several different ways to administer the trans- plant, including via endoscopy, rectally as an enema, via nasogastric/nasoenteral tube (tube passed through the nose into the stomach/upper part of the small intestine), or via oral ingestion of capsules that contain faecal material. The transplant may either be administered fresh (i.e. immedi- ately 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 pop- ulations as a complication of antibiotic use. Despite adequate treatment, Clostridium difficile infection recurs in

    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.

    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

    published evidence is currently lacking. This included the evaluation of the use of FMT in the treatment of Clostridium difficile infection (CDI; also referred to as Clostridioides difficile [1]), and also in potential non-CDI indications. Rele- vant guidance published to date includes the interventional procedure guidance from the National Institute for Health and Care Excellence (NICE) [2], UK, European and US microbiolog- ical guidelines on the treatment of CDI [3e5], and recent expert consensus documents on FMT in clinical practice [6,7]. Furthermore, there have also been national recommendations regarding FMT produced by working groups in several different countries [8e10]. Principally as a result of randomised studies that have been published in recent years [11e18], FMT has become an accepted treatment for recurrent/refractory CDI.

    The unique remit and objectives of this guideline when commissioned by the BSG and HIS were:

    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 con- ditions, much of which has been published after the publication of current CDI treatment algorithms [3,4].

    ii. To provide specific guidance about best practice for an FMT service within the context of the regulatory frame- work for the intervention as it currently exists in the UK [19,20].

    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 modality [21]. Previous research has demonstrated that commensal bacteria cultured from the stool of healthy donors [22], sterile faecal filtrate [23], and/or spores of Firmicutes derived from ethanol-treated stool from healthy donors [24] may have similar efficacy to conventional FMT in treating CDI, although results of the latter approach produced disap- pointing outcome data when extended to a Phase II clinical trial [25]. For the purposes of this guideline, the BSG/HIS working group considered only studies that used the admin- istration of manipulated whole stool (including encapsulated faeces). They deemed studies using cultured microorganisms

    http://crossmark.crossref.org/dialog/?doi=10.1016/j.jhin.2018.07.037&domain=pdf

  • B.H. Mullish et al. / Journal of Hospital Infection 100 (2018) S1eS31 S3

    (or their proteins, metabolites or other components), or microbiota suspensions, to be in the pre-clinical research stage, without firm evidence.

    FMT has been shown to be very acceptable to patients, both in the setting of CDI [11,26] and in non-CDI settings, e.g. ul- cerative colitis [27]. However, the absence of appropriate protocols [28e31] specifically

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