Evidence map›Paper›PMID 39932857›Full record

ArticleInflammatory bowel diseases2025

Guidance for Fecal Microbiota Transplantation Trials in Ulcerative Colitis: The Second ROME Consensus Conference.

Loris R Lopetuso, Sara Deleu, Pierluigi Puca, Maria Teresa Abreu, Alessandro Armuzzi, Giovanni Barbara, Flavio Caprioli, Siew Chieng, Samuel Paul Costello, Andrea Damiani and 38 more

Abstract readConsensus Statement
In one paragraph

Article in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

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  11. Enteric nervous system as a therapeutic target in gastrointestinal disorders.World journal of gastrointestinal pharmacology and therapeutics · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

48 authors.

Loris R LopetusoIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-5747-2055
Sara DeleuIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0001-8596-2783
Pierluigi PucaIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0003-0935-8853
Maria Teresa AbreuDivision of Gastroenterology, Department of Medicine, Crohn's and Colitis Center, University of Miami - Miller School of Medicine, Miami, FL, USA.
Alessandro ArmuzziIBD Unit, IRCCS Humanitas Research Hospital, Milan, Italy.ORCID 0000-0003-1572-0118
Giovanni BarbaraDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Rome, Italy.
Flavio CaprioliGastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0000-0002-8077-8175
Siew ChiengDepartment of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.ORCID 0000-0002-6850-4454
Samuel Paul CostelloDepartment of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, SA, Australia.
Andrea DamianiReal World Data Facility, Gemelli Generator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Silvio DaneseDepartment of Gastroenterology and Digestive Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.ORCID 0000-0001-7341-1351
Federica Del ChiericoImmunology, Rheumatology and Infectious Diseases Research Area, Unit of Human Microbiome, Bambino Gesù Children's Hospital IRCCS, Rome, Italy.ORCID 0000-0002-4204-4736
Geert D'HaensDepartment of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.ORCID 0000-0003-2784-4046
Iris DotanDivision of Gastroenterology, Rabin Medical Center, Petah-Tikva, Israel.
Federica FacciottiDipartimento di Biotecnologie e Bioscienze, Università di Milano-Bicocca, Milan, Italy.ORCID 0000-0002-2541-9428
Gwen FalonyInstitute of Medical Microbiology and Hygiene and Research Center for Immunotherapy (FZI), University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.ORCID 0000-0003-2450-0782
Massimo Claudio FantiniDepartment of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.ORCID 0000-0002-8164-2587
Gionata FiorinoIBD Unit, San Camillo-Forlanini Hospital, Rome, Italy.ORCID 0000-0001-5623-2968
Paolo GionchettiDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.ORCID 0000-0001-9479-5307
Lihi GodnyDivision of Gastroenterology, Rabin Medical Center, Petah-Tikva, Israel.ORCID 0000-0001-7758-6466
Ailsa HartIBD Unit, St Mark's Hospital, Harrow, Middlesex, UK.
Juozas KupčinskasDepartment of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania.ORCID 0000-0002-8760-7416
Tariq IqbalMicrobiome Treatment Center, University of Birmingham, Birmingham, UK.ORCID 0000-0002-6681-9882
Lucrezia LaterzaIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0001-5515-1197
Letizia LombardiniCentro Nazionale Trapianti (CNT), Istituto Superiore di Sanità, Rome, Italy.
Nitsan MaharshakDivision of Gastroenterology, Rabin Medical Center, Petah-Tikva, Israel.ORCID 0000-0002-9324-0024
Giovanni MarascoIRCCS Azienda Ospedaliero Universitaria Di Bologna, Bologna, Italy.ORCID 0000-0001-7167-8773
Luca MasucciMicrobiology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-8358-6726
Alfredo PapaIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-4186-7298
Sudarshan ParamsothyGastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney, Australia.ORCID 0000-0002-9097-6028
Valentina PetitoIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0003-4396-1613
Daniele PiovaniDepartment of Biomedical Sciences, Humanitas University, Milan, Italy.ORCID 0000-0002-1414-6639
Daniela PuglieseIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0001-7930-5402
Lorenza PutignaniUnit 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.ORCID 0000-0003-0134-2830
Jeroen RaesDepartment of Microbiology and Immunology, KU Leuven, Leuven, Belgium.
Davide Giuseppe RibaldoneDepartment of Medical Sciences, Unit of Gastroenterology, University of Turin, Turin, Italy.ORCID 0000-0002-9421-3087
Maurizio SanguinettiMicrobiology Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-9780-7059
Edoardo Vincenzo SavarinoGastroenterology Unit, Azienda  Ospedaliera di Padova, Padova, Italy.ORCID 0000-0002-3187-2894
Harry SokolINSERM, Centre de Recherche Saint-Antoine, CRSA, Sorbonne Université, Paris, France.ORCID 0000-0002-2914-1822
Stefania VetranoLaboratory of Gastrointestinal Immunopathology, Humanitas Research Hospital, Milan, Italy.ORCID 0000-0001-9825-2000
Gianluca IaniroDipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID 0000-0002-8318-0515
Giovanni CammarotaDipartimento di Scienze Mediche e Chirurgiche, UOC di Medicina Interna e Gastroenterologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-3626-6148
Fabio CominelliDivision of Gastroenterology and Liver Diseases, Case Western Reserve University School of Medicine, Cleveland, OH, USA.ORCID 0000-0002-1571-1548
Theresa T PizarroDepartment of Pathology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Herbert TilgDepartment of Gastroenterology, Saint Antoine Hospital, Paris, France.
Antonio GasbarriniDipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID 0000-0003-4863-6924
Severine VermeireDepartment of Chronic Diseases, Metabolism (CHROMETA), KU Leuven, Leuven, Belgium.ORCID 0000-0001-9942-3019
Franco ScaldaferriIBD Unit, CEMAD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID 0000-0001-8334-7541

Funding

Crohn's & Colitis Foundation: Clinical Research Investigator Initiated Award (CRIA)European Crohn's and Colitis OrganizationSenior Research Award (SRA) 882725
6 · The paper itself

Abstract

backgroundFecal 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.

methodsGlobal 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

conclusionsThe 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.

Indexed as

Colitis, UlcerativeFecal Microbiota TransplantationPractice Guidelines as TopicConsensusFecesHumansRandomized Controlled Trials as Topicclinical trialsfecal microbiota transplantation (FMT)FMT guidelinesulcerative colitis (UC)

Identifiers

PMID39932857
PMCPMC12455609

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.