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Efficacy and Safety of Fecal Microbiota Transplantation by Oral Capsules in Patients With Liver
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Fondazione Policlinico Agostino Gemelli IRCCS
Rome, Italy
Start Date
April 7, 2021
Primary Completion Date
June 1, 2025
Completion Date
June 1, 2025
Last Updated
April 16, 2024
60
ESTIMATED participants
Fecal microbiota transplantation delivery through colonoscopy
PROCEDURE
Fecal microbiota transplantation delivery through oral capsules
DRUG
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06052176