Inflamm Bowel Dis. 2025 Feb 11:izaf013. doi: 10.1093/ibd/izaf013. Online ahead of print.

Loris R Lopetuso ^1 2, Sara Deleu ^1 3 4, Pierluigi Puca ^1 4, Maria Teresa Abreu ⁵, Alessandro Armuzzi ^6 7, Giovanni Barbara ^8 9, Flavio Caprioli ^10 11, Siew Chieng ¹², Samuel Paul Costello ¹³, Andrea Damiani ¹⁴, Silvio Danese ¹⁵, Federica Del Chierico ¹⁶, Geert D'Haens ¹⁷, Iris Dotan ¹⁸, Federica Facciotti ¹⁹, Gwen Falony ²⁰, Massimo Claudio Fantini ^21 22, Gionata Fiorino ²³, Paolo Gionchetti ^24 25, Lihi Godny ¹⁸, Ailsa Hart ²⁶, Juozas Kupcinskas ²⁷, Tariq Iqbal ²⁸, Lucrezia Laterza ^1 4, Letizia Lombardini ²⁹, Nitsan Maharshak ¹⁸, Giovanni Marasco ^9 30, Luca Masucci ³¹, Alfredo Papa ¹, Sudarshan Paramsothy ³², Valentina Petito ¹, Daniele Piovani ⁷, Daniela Pugliese ^1 4, Lorenza Putignani ³³, Jeroen Raes ^34 35, Davide Giuseppe Ribaldone ³⁶, Maurizio Sanguinetti ³¹, Edoardo Vincenzo Savarino ³⁷, Harry Sokol ^38 39, Stefania Vetrano ^40 41, Gianluca Ianiro ^4 42, Giovanni Cammarota ⁴², Fabio Cominelli ⁴³, Theresa T Pizarro ⁴⁴, Herbert Tilg ^39 45, Antonio Gasbarrini ^4 42, Severine Vermeire ^3 46, Franco Scaldaferri ^1 4

Author information

¹IBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

²Department of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.

³Department of Chronic Diseases, Metabolism (CHROMETA), KU Leuven, Leuven, Belgium.

⁴Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.

⁵Division of Gastroenterology, Department of Medicine, Crohn's and Colitis Center, University of Miami - Miller School of Medicine, Miami, FL, USA.

⁶IBD Unit, IRCCS Humanitas Research Hospital, Milan, Italy.

⁷Department of Biomedical Sciences, Humanitas University, Milan, Italy.

⁸Department of Medical and Surgical Sciences, University of Bologna, Bologna, Rome, Italy.

⁹IRCCS Azienda Ospedaliero Universitaria Di Bologna, Bologna, Italy.

¹⁰Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

¹¹Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.

¹²Department of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.

¹³Department of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, SA, Australia.

¹⁴Real World Data Facility, Gemelli Generator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

¹⁵Department of Gastroenterology and Digestive Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.

¹⁶Immunology, Rheumatology and Infectious Diseases Research Area, Unit of Human Microbiome, Bambino Gesù Children's Hospital IRCCS, Rome, Italy.

¹⁷Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.

¹⁸Division of Gastroenterology, Rabin Medical Center, Petah-Tikva, Israel.

¹⁹Dipartimento di Biotecnologie e Bioscienze, Università di Milano-Bicocca, Milan, Italy.

²⁰Institute of Medical Microbiology and Hygiene and Research Center for Immunotherapy (FZI), University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.

²¹Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.

²²Gastroenterology Unit, Azienda Ospedaliero-Universitaria di Cagliari, Cagliari, Italy.

²³IBD Unit, San Camillo-Forlanini Hospital, Rome, Italy.

²⁴Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

²⁵IBD Unit, IRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna,, Italy.

²⁶IBD Unit, St Mark's Hospital, Harrow, Middlesex, UK.

²⁷Department of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania.

²⁸Microbiome Treatment Center, University of Birmingham, Birmingham, UK.

²⁹Centro Nazionale Trapianti (CNT), Istituto Superiore di Sanità, Rome, Italy.

³⁰Department of Medical and Surgical Sciences, University of Bologna, Bologna,, Italy.

³¹Microbiology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

³²Gastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney, Australia.

³³Unit of Microbiology and Diagnostic Immunology, Unit of Microbiomics and Research Area of Immunology, Rheumatology and Infectious Diseases, Unit of Human Microbiome, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.

³⁴Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.

³⁵Center for Microbiology, VIB, Gent, Belgium.

³⁶Department of Medical Sciences, Unit of Gastroenterology, University of Turin, Turin, Italy.

³⁷Gastroenterology Unit, Azienda  Ospedaliera di Padova, Padova, Italy.

³⁸INSERM, Centre de Recherche Saint-Antoine, CRSA, Sorbonne Université, Paris, France.

³⁹Department of Gastroenterology, Saint Antoine Hospital, Paris, France.

⁴⁰Laboratory of Gastrointestinal Immunopathology, Humanitas Research Hospital, Milan, Italy.

⁴¹Department of Biomedical Sciences, Humanitas University, Milan, Italy.

⁴²Dipartimento di Scienze Mediche e Chirurgiche, UOC di Medicina Interna e Gastroenterologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.

⁴³Division of Gastroenterology and Liver Diseases, Case Western Reserve University School of Medicine, Cleveland, OH, USA.

⁴⁴Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.

⁴⁵Department of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology and Metabolism, Medical University of Innsbruck, Innsbruck, Austria.

⁴⁶Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

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.