Gut. 2023 Sep;72(9):1642-1650. doi: 10.1136/gutjnl-2023-329948. Epub 2023 Jun 20.

Loris Riccardo Lopetuso ^# 1 2 3, Sara Deleu ^# 4, Lihi Godny ⁵, Valentina Petito ⁶, Pierluigi Puca ^6 7, Federica Facciotti ⁸, Harry Sokol ⁹, Gianluca Ianiro ^7 10, Luca Masucci ¹¹, Maria Abreu ¹², Iris Dotan ⁵, Samuel Paul Costello ¹³, Ailsa Hart ¹⁴, Tariq H Iqbal ¹⁵, Sudarshan Paramsothy ¹⁶, Maurizio Sanguinetti ¹¹, Silvio Danese ¹⁷, Herbert Tilg ¹⁸, Fabio Cominelli ¹⁹, Theresa T Pizarro ²⁰, Alessandro Armuzzi ^21 22, Giovanni Cammarota ^7 10, Antonio Gasbarrini ^6 7 10, Séverine Vermeire ^# 4, Franco Scaldaferri ^# 6 7

Author information

¹IBD Unit, CEMAD Centro Malattie dell'Apparato Digerente, UOC di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy lopetusoloris@gmail.com.

²Department of Medicine and Ageing Sciences, "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy.

³Center for Advanced Studies and Technology (CAST), "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy.

⁴Department of Chronic Diseases & Metabolism (CHROMETA), KU Leuven, Leuven, Belgium.

⁵Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.

⁶IBD Unit, CEMAD Centro Malattie dell'Apparato Digerente, UOC di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.

⁷Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Roma, Italy.

⁸Dipartimento di Biotecnologie e Bioscienze, University of Milan-Bicocca, Milano, Italy.

⁹INSERM, Centre de Recherche Saint-Antoine, CRSA, AP-HP, Saint Antoine Hospital, Gastroenterology Department, Sorbonne Universite, Paris, France.

¹⁰UOC di Medicina Interna e Gastroenterologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.

¹¹Department of Laboratory Sciences and Infectious Diseases, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.

¹²Department of Medicine, Division of Gastroenterology, Crohn's and Colitis Center, University of Miami Miller School of Medicine, Miami, Florida, USA.

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

¹⁴IBD Unit, Saint Mark's Hospital, Harrow, UK.

¹⁵Microbiome Treatment Center, University of Birmingham, Birmingham, UK.

¹⁶Gastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.

¹⁷Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milano, Italy.

¹⁸Department of Internal Medicine I, Gastroenterology, Hepatology, Endocrinology & Metabolism, Medizinische Universitat Innsbruck, Innsbruck, Austria.

¹⁹Division of Gastroenterology and Liver Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

²⁰Department of Pathology, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.

²¹Deparment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milano, Italy.

²²IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milano, Italy.

^#Contributed equally.

Abstract

Background: Several randomised clinical trials (RCTs) performing faecal microbiota transplantation (FMT) for the management of inflammatory bowel disease (IBD), particularly for ulcerative colitis, have recently been published, but with major variations in study design. These include differences in administered dose, route and frequency of delivery, type of placebo and evaluated endpoints. Although the overall outcomes appear to be promising, they are highly dependent on both donor and recipient factors.

Objective: To develop concensus-based statements and recommendations for the evaluation, management and potential treatment of IBD using FMT in order to move towards standardised practices.

Design: An international panel of experts convened several times to generate evidence-based guidelines by performing a deep evaluation of currently available and/or published data. Twenty-five experts in IBD, immunology and microbiology collaborated in different working groups to provide statements on the following key issues related to FMT in IBD: (A) pathogenesis and rationale, (B) donor selection and biobanking, (C) FMT practices and (D) consideration of future studies and perspectives. Statements were evaluated and voted on by all members using an electronic Delphi process, culminating in a plenary consensus conference and generation of proposed guidelines.

Results and conclusions: Our group has provided specific statements and recommendations, based on best available evidence, with the end goal of providing guidance and general criteria required to promote FMT as a recognised strategy for the treatment of IBD.