Randomised, double-blind, placebo-controlled trial of faecal microbiota transplantation in patients with decompensated cirrhosis: the Livergut protocol
Year: 2026
Type: article
Study design: Study Protocol
Abstract: Introduction Cirrhosis represents the final stage of most chronic liver diseases and remains a major global cause of morbidity and mortality. Alterations in the gut microbiome correlate with disease severity and complications such as hepatic encephalopathy (HE) and acute-on-chronic liver failure (ACLF). Preliminary evidence suggests that faecal microbiota transplantation (FMT) is safe and could be effective in preventing disease progression, but data remain limited. Methods and analysis The LiverGut Trial is a phase III, multicentre, double-blind, placebo-controlled, randomised clinical trial designed to evaluate the safety and efficacy of FMT in patients with decompensated cirrhosis. A total of 190 adult patients (≥18 years) with decompensated cirrhosis will be enrolled across 8 Spanish tertiary hospitals. Participants will be randomised (1:1) to receive FMT or placebo capsules, administered orally in two treatment cycles (24 capsules per cycle, over two consecutive days) at entry into the study and at month 3. The primary endpoint is the time to the first new decompensation event (ascites, bacterial infection, gastrointestinal bleeding, HE or acute kidney injury). Ethics and dissemination The study protocol has been approved by the Ethics Committee of Hospital Clinic de Barcelona (HCB/2024/0805) and by the Spanish Agency for Medicines and Medical Devices through the Clinical Trial Information System (CTIS, European Union Clinical Trials No 2023-5 09 151-13-00) and will be conducted in accordance with the Declaration of Helsinki. The trial has been registered in ClinicalTrials.gov (NCT06533852). Results will be disseminated via CTIS, ClinicalTrials.gov, peer-reviewed journals and scientific conferences. Trial registration number EU CT No 2023-5 09 151-13-00 (protocol V.2.0, 25 February 2025); https://clinicaltrials.gov/study/NCT06533852.
Source: BMJ Open
Authors: Adrià Juanola, Maria José Moreta, Cristina Solé, Jordi Sánchez, Agustin Albillos, Javier Martínez González, Maria Poca Sans, Edilmar Alvarado, Isabel Campos-Varela, Carlos Cespedes, Sonia Alonso, Rafael Bañares, José Ignacio Fortea, Ángela Puente, Elba Llop, Carlos Fernández-Carrillo, Andres Moya, Susana Ruiz-Ruiz, Jose Manuel Fernandez-Real, Jordi Mayneris-Perxachs, Eva Bonfill, Carlota Rivera, Judit Pich, Salvatore Piano, Elsa Solà, Ferran Torres, Selene Iavarone, Martina Pérez-Guasch, Nicole C Casanova, Begona González-Suárez, Núria Fabrellas, Isabel Graupera, Elisa Pose, Pere Ginès
Institutions: Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Comunidad de Madrid, Universitat Autònoma de Barcelona, Corporació Sanitària Parc Taulí, Institute of Research and Innovation Parc Tauli, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria, Hospital Universitario Ramón y Cajal, Hospital de Sant Pau, Vall d'Hebron Hospital Universitari, Hospital General Universitario Gregorio Marañón, Marqués de Valdecilla University Hospital, Fundación Marques de Valdecilla, Hospital Universitario Puerta de Hierro Majadahonda, Universitat de València, Institute for Integrative Systems Biology, Hospital Universitari de Girona Doctor Josep Trueta, Institut d'Investigació Biomèdica de Girona, University of Padua, Stanford University, Universitat de Barcelona, Centro de Investigación Biomédica en Red
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,839
OpenAlex ID: W7221854056