protocolSection identificationModule nctId: NCT06368895, orgStudyIdInfo id: 2188, briefTitle: Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-07, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.The aims of the study are:To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement., conditionsModule conditions: Hepatic Encephalopathy, conditions: Dysbiosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Fecal microbiota transplantation delivery through colonoscopy, interventions name: Fecal microbiota transplantation delivery through oral capsules, outcomesModule primaryOutcomes measure: Evaluation of safety of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy, primaryOutcomes measure: Evaluation of efficacy of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy, secondaryOutcomes measure: Evaluation of changes in the gut microbiota composition following the fecal microbiota transplantation, secondaryOutcomes measure: Evaluation of changes in the systemic inflammatory following the fecal microbiota transplantation, secondaryOutcomes measure: Evaluation of changes in the intestinal inflammatory following the fecal microbiota transplantation, secondaryOutcomes measure: Comparison between protein metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation, secondaryOutcomes measure: Comparison between lipid metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation, secondaryOutcomes measure: Comparison between carbohydrates metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Agostino Gemelli IRCCS, status: RECRUITING, city: Rome, zip: 00168, country: Italy, contacts name: Francesca Ponziani, MD, role: CONTACT, phone: +390630156018, email: comitato.etico@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False