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      International consensus conference on stool banking for faecal microbiota transplantation in clinical practice

      research-article
      1 , , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 24 , 11 , 21 , 26 , 27 , 28 , 29 , 30 , 31
      Gut
      BMJ Publishing Group
      clostridioides difficile, fecal microbiota transplantation, guideline, microbiota, stool bank

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          Abstract

          Although faecal microbiota transplantation (FMT) has a well-established role in the treatment of recurrent Clostridioides difficile infection (CDI), its widespread dissemination is limited by several obstacles, including lack of dedicated centres, difficulties with donor recruitment and complexities related to regulation and safety monitoring. Given the considerable burden of CDI on global healthcare systems, FMT should be widely available to most centres.

          Stool banks may guarantee reliable, timely and equitable access to FMT for patients and a traceable workflow that ensures safety and quality of procedures. In this consensus project, FMT experts from Europe, North America and Australia gathered and released statements on the following issues related to the stool banking: general principles, objectives and organisation of the stool bank; selection and screening of donors; collection, preparation and storage of faeces; services and clients; registries, monitoring of outcomes and ethical issues; and the evolving role of FMT in clinical practice,

          Consensus on each statement was achieved through a Delphi process and then in a plenary face-to-face meeting. For each key issue, the best available evidence was assessed, with the aim of providing guidance for the development of stool banks in order to promote accessibility to FMT in clinical practice.

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          Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial.

          Ulcerative colitis (UC) is difficult to treat, and standard therapy does not always induce remission. Fecal microbiota transplantation (FMT) is an alternative approach that induced remission in small series of patients with active UC. We investigated its safety and efficacy in a placebo-controlled randomized trial.
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            Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.

            The intestinal microbiota is implicated in the pathogenesis of ulcerative colitis. Faecal microbiota transplantation is a novel form of therapeutic microbial manipulation, but its efficacy in ulcerative colitis is uncertain. We aimed to establish the efficacy of intensive-dosing, multidonor, faecal microbiota transplantation in active ulcerative colitis.
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              European consensus conference on faecal microbiota transplantation in clinical practice

              Faecal microbiota transplantation (FMT) is an important therapeutic option for Clostridium difficile infection. Promising findings suggest that FMT may play a role also in the management of other disorders associated with the alteration of gut microbiota. Although the health community is assessing FMT with renewed interest and patients are becoming more aware, there are technical and logistical issues in establishing such a non-standardised treatment into the clinical practice with safety and proper governance. In view of this, an evidence-based recommendation is needed to drive the practical implementation of FMT. In this European Consensus Conference, 28 experts from 10 countries collaborated, in separate working groups and through an evidence-based process, to provide statements on the following key issues: FMT indications; donor selection; preparation of faecal material; clinical management and faecal delivery and basic requirements for implementing an FMT centre. Statements developed by each working group were evaluated and voted by all members, first through an electronic Delphi process, and then in a plenary consensus conference. The recommendations were released according to best available evidence, in order to act as guidance for physicians who plan to implement FMT, aiming at supporting the broad availability of the procedure, discussing other issues relevant to FMT and promoting future clinical research in the area of gut microbiota manipulation. This consensus report strongly recommends the implementation of FMT centres for the treatment of C. difficile infection as well as traces the guidelines of technicality, regulatory, administrative and laboratory requirements.
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                Author and article information

                Journal
                Gut
                Gut
                gutjnl
                gut
                Gut
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0017-5749
                1468-3288
                December 2019
                28 September 2019
                : 68
                : 12
                : 2111-2121
                Affiliations
                [1 ] departmentInternal Medicine and Gastroenterology, Day Hospital of Gastroenterology and Intestinal Microbiota Transplantation , Fondazione Policlinico A Gemelli IRCCS, Catholic University of Medicine , Roma, Italy
                [2 ] departmentInternal Medicine and Gastroenterology, Day Hospital of Gastroenterology and Intestinal Microbiota Transplantation , Fondazione Policlinico A Gemelli IRCCS , Roma, Italy
                [3 ] departmentDivision of Gastroenterology , Alpert Medical School of Brown University , Providence, Rhode Island, United States of America
                [4 ] departmentDepartment of Metabolism, Digestion and Reproduction, Faculty of Medicine , Imperial College London , London, United Kingdom
                [5 ] departmentDivision of Gastroenterology , Brigham and Women’s Hospital, Harvard Medical School , Boston, Massachusetts, United States of America
                [6 ] departmentMicrobiome Informatics , Massachusetts Institute of Technology , Cambridge, Massachusetts, United States of America
                [7 ] OpenBiome , Somerville, Massachusetts, United States of America
                [8 ] departmentParasitology Unit and Human Microbiome Unit , Bambino Gesù Pediatric Hospital , Roma, Italy
                [9 ] departmentDepartment of Medicine , Indiana University , Indianapolis, Indiana, United States of America
                [10 ] departmentDepartment of Gastroenterologyand Hepatology , Haaglanden Medical Center, 2597 AX , The Hague, Netherlands
                [11 ] National Donor Feces Bank, LUMC , Leiden, the Netherlands
                [12 ] departmentDepartment of Gastroenterology , The Queen Elizabeth Hospital, University of Adelaide , Woodville, South Australia, Australia
                [13 ] departmentService de Gastroenterologie , Hôpital Saint Antoine, Sorbonne Université, Inserm, Centre de Recherche Saint-Antoine , Paris, France
                [14 ] French Group of Fecal Microbiota Transplantation , Paris, France
                [15 ] departmentINRA, UMR1319 Micalis , AgroParisTech , Jouy-en-Josas, France
                [16 ] departmentDivision of Gastroenterology and Hepatology, Department of Internal Medicine , Medical University of Graz , Graz, Austria
                [17 ] departmentHuman Microbiome Research Program , Faculty of Medicine, University of Helsinki , Helsinki, Finland
                [18 ] departmentDivision of Gastroenterology, Hepatology and Nutrition , Boston Children's Hospital , Boston, Massachusetts, Uunited States of America
                [19 ] departmentDivision of Gastroenterology, Department of Medicine , University of Alberta , Edmonton, Alberta, Canada
                [20 ] departmentDepartment of Clinic of Gastroenterology , University of Helsinki and Helsinki University Hospital , Helsinki, Finland
                [21 ] departmentDepartment of Medical Microbiology , Leiden University Medical Centre , Leiden, the Netherlands
                [22 ] departmentDepartment I of Internal Medicine; German Centre for Infection Research, Partner site Bonn-Cologne , University Hospital of Cologne , Cologne, Germany
                [23 ] departmentTissues and Cells Area , Italian National Transplant Center , Rome, Italy
                [24 ] departmentInternal Medicine and Gastroenterology , Fondazione Policlinico A Gemelli IRCCS , Roma, Italy
                [25 ] departmentMicrobiology , Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Catholic University of Medicine , Roma, Italy
                [26 ] departmentDepartment of Internal Medicine , Amsterdam University Medical Centers, location AMC and VuMC , Amsterdam, Netherlands
                [27 ] departmentGastroenterology and Hepatology Department , Hospital Universitario Ramon y Cajal , Madrid, Spain
                [28 ] departmentDepartment of Gastroenterology , Institute for Digestive Research, Medical Academy, Lithuanian University of Health Sciences , Kaunas, Lithuania
                [29 ] departmentDepartment of Gastroenterology , St Mark's Hospital , London, United Kingdom
                [30 ] departmentDepartment of Internal Medicine I, Gastroenterology, Endocrinology & Metabolism , Innsbruck Medical University , Innsbruck, Austria
                [31 ] departmentInternal Medicine and Gastroenterology , Fondazione Policlinico A Gemelli IRCCS, Catholic University of Medicine , Roma, Italy
                Author notes
                [Correspondence to ] Professor Giovanni Cammarota, Internal Medicine and Gastroenterology, Fondazione Policlinico A Gemelli IRCCS, Roma 00168, Italy; giovanni.cammarota@ 123456unicatt.it

                GC and GI are joint first authors.

                Author information
                http://orcid.org/0000-0002-3626-6148
                http://orcid.org/0000-0001-6300-3100
                Article
                gutjnl-2019-319548
                10.1136/gutjnl-2019-319548
                6872442
                31563878
                875bf965-e905-419e-a218-af351ab74ebf
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 26 July 2019
                : 10 September 2019
                : 22 September 2019
                Categories
                Guidelines
                1506
                2312
                Custom metadata
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                Gastroenterology & Hepatology
                clostridioides difficile,fecal microbiota transplantation,guideline,microbiota,stool bank

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