Loris R Lopetuso, Sara Deleu, Pierluigi Puca, Maria Teresa Abreu, Alessandro Armuzzi, Giovanni Barbara, Flavio Caprioli, Siew Chieng, Samuel Paul Costello, Andrea Damiani, Silvio Danese, Federica Del Chierico, Geert D'Haens, Iris Dotan, Federica Facciotti, Gwen Falony, Massimo Claudio Fantini, Gionata Fiorino, Paolo Gionchetti, Lihi Godny, Ailsa Hart, Juozas Kupčinskas, Tariq Iqbal, Lucrezia Laterza, Letizia Lombardini, Nitsan Maharshak, Giovanni Marasco, Luca Masucci, Alfredo Papa, Sudarshan Paramsothy, Valentina Petito, Daniele Piovani, Daniela Pugliese, Lorenza Putignani, Jeroen Raes, Davide Giuseppe Ribaldone, Maurizio Sanguinetti, Edoardo Vincenzo Savarino, Harry Sokol, Stefania Vetrano, Gianluca Ianiro, Giovanni Cammarota, Fabio Cominelli, Theresa T Pizarro, Herbert Tilg, Antonio Gasbarrini, Severine Vermeire, Franco Scaldaferri
{"title":"Guidance for Fecal Microbiota Transplantation Trials in Ulcerative Colitis: The Second ROME Consensus Conference.","authors":"Loris R Lopetuso, Sara Deleu, Pierluigi Puca, Maria Teresa Abreu, Alessandro Armuzzi, Giovanni Barbara, Flavio Caprioli, Siew Chieng, Samuel Paul Costello, Andrea Damiani, Silvio Danese, Federica Del Chierico, Geert D'Haens, Iris Dotan, Federica Facciotti, Gwen Falony, Massimo Claudio Fantini, Gionata Fiorino, Paolo Gionchetti, Lihi Godny, Ailsa Hart, Juozas Kupčinskas, Tariq Iqbal, Lucrezia Laterza, Letizia Lombardini, Nitsan Maharshak, Giovanni Marasco, Luca Masucci, Alfredo Papa, Sudarshan Paramsothy, Valentina Petito, Daniele Piovani, Daniela Pugliese, Lorenza Putignani, Jeroen Raes, Davide Giuseppe Ribaldone, Maurizio Sanguinetti, Edoardo Vincenzo Savarino, Harry Sokol, Stefania Vetrano, Gianluca Ianiro, Giovanni Cammarota, Fabio Cominelli, Theresa T Pizarro, Herbert Tilg, Antonio Gasbarrini, Severine Vermeire, Franco Scaldaferri","doi":"10.1093/ibd/izaf013","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Fecal microbiota transplantation (FMT) is emerging as a potential treatment modality for individuals living with inflammatory bowel disease (IBD). Despite its promise, the effectiveness of FMT for treating IBD, particularly for ulcerative colitis (UC), still requires thorough clinical investigation. Notwithstanding differences in methodologies, current studies demonstrate its potential for inducing remission in UC patients. Therefore, standardized and robust randomized clinical trials (RCTs) are needed to further support its efficacy for managing UC. The aim of the second Rome Consensus Conference was to address gaps and uncertainties identified in previous research regarding FMT and to offer a robust framework for future studies applied to the treatment of UC.</p><p><strong>Methods: </strong>Global experts in the field of clinical IBD, mucosal immunology, and microbiology (N = 48) gathered to address the need for standardized clinical trials in FMT investigation. The group focused on key issues, such as stool donation, donor selection, characterization of fecal biomass, potential administration routes, as well as the process of induction, maintenance, and endpoint readouts.</p><p><strong>Results and conclusions: </strong>The consensus achieved during this conference established standardization of methods and protocols to enhance the current quality of research, with the aim of eventual implementation of FMT in managing UC and the ultimate goal of improving patient outcomes.</p>","PeriodicalId":13623,"journal":{"name":"Inflammatory Bowel Diseases","volume":" ","pages":""},"PeriodicalIF":4.5000,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Inflammatory Bowel Diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ibd/izaf013","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Fecal microbiota transplantation (FMT) is emerging as a potential treatment modality for individuals living with inflammatory bowel disease (IBD). Despite its promise, the effectiveness of FMT for treating IBD, particularly for ulcerative colitis (UC), still requires thorough clinical investigation. Notwithstanding differences in methodologies, current studies demonstrate its potential for inducing remission in UC patients. Therefore, standardized and robust randomized clinical trials (RCTs) are needed to further support its efficacy for managing UC. The aim of the second Rome Consensus Conference was to address gaps and uncertainties identified in previous research regarding FMT and to offer a robust framework for future studies applied to the treatment of UC.
Methods: Global experts in the field of clinical IBD, mucosal immunology, and microbiology (N = 48) gathered to address the need for standardized clinical trials in FMT investigation. The group focused on key issues, such as stool donation, donor selection, characterization of fecal biomass, potential administration routes, as well as the process of induction, maintenance, and endpoint readouts.
Results and conclusions: The consensus achieved during this conference established standardization of methods and protocols to enhance the current quality of research, with the aim of eventual implementation of FMT in managing UC and the ultimate goal of improving patient outcomes.
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Inflammatory Bowel Diseases® supports the mission of the Crohn''s & Colitis Foundation by bringing the most impactful and cutting edge clinical topics and research findings related to inflammatory bowel diseases to clinicians and researchers working in IBD and related fields. The Journal is committed to publishing on innovative topics that influence the future of clinical care, treatment, and research.
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