Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

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.

Inclusion Criteria:

• Diagnosis of liver cirrhosis
• Hepatic encephalopathy of grade >1 or higher according to West Haven classification, persistent or recurrent despite treatment with lactulose/lactitol and rifaximin at adequate doses started at least 30 days before the Hepatic encephalopathy episode

Exclusion Criteria:

• Na <130 meq /l
• Creatinine > 1.3 mg / dl
• Presence of grade 3 ascites
• Presence of esophagogastric varices at risk of haemorrhage in the absence of adequate prophylaxis
• Presence of other possible causes of encephalopathy (cerebral vascular disease, known neurodegenerative or cognitive disorders)
• Known psychiatric disorders or other causes of brain dysfunction (e.g. hypoglycemia, hyponatremia)
• Alcohol consumption
• Diagnosis of hepatocellular carcinoma
• Contraindication to fecal microbiota transplantation (e.g. pregnancy or breastfeeding)
• Presence of known intestinal diseases
• Any clinical condition that, in the opinion of the investigators, may contraindicate the enrollment in the study