Guidance for Fecal Microbiota Transplantation Trials in Ulcerative Colitis: The Second ROME Consensus Conference
Loris Riccardo Lopetuso, S Deleu, Pierluigi Puca, María T. Abreu, Alessandro Armuzzi, Giovanni Barbara, Flavio Caprioli, Siew C. Ng, Samuel P. Costello, Andrea Damiani, Silvio Danese, Federica Del Chierico, Geert D’Haens, Iris Dotan, Federica Facciotti, Gwen Falony, Massimo 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 Savarino, Harry Sokol, Stefania Vetrano, Gianluca Ianiro, Giovanni Cammarota, Fabio Cominelli, Theresa T. Pizarro, Herbert Tilg, Antonio Gasbarrini, Séverine Vermeire, Franco Scaldaferri
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.