Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

Institute of Hospitalization and Scientific Care (IRCCS)

Status and phase: Enrolling; Phase 1

Conditions: Dysbiosis; Hepatic Encephalopathy

Treatments: Procedure: Fecal microbiota transplantation delivery through colonoscopy; Drug: Fecal microbiota transplantation delivery through oral capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06368895

2188 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Fecal microbiota transplantation through colonoscopy and oral capsules

Experimental group

Description:

Patients with cirrhosis and hepatic encephalopathy refractory to conventional treatment will undergo a two-stage fecal microbiota transplantation: initial colonoscopic delivery followed by daily oral capsules administration one month later. Patients will continue also conventional therapy with rifaximin and lactulose

Treatment:

Procedure: Fecal microbiota transplantation delivery through colonoscopy

Drug: Fecal microbiota transplantation delivery through oral capsules

Fecal microbiota transplantation through oral capsules

Experimental group

Description:

Patients with cirrhosis and hepatic encephalopathy refractory to conventional treatment will undergo fecal microbiota transplantation through daily oral capsules administration. Patients will continue also conventional therapy with rifaximin and lactulose.

Treatment:

Drug: Fecal microbiota transplantation delivery through oral capsules

Controls

No Intervention group

Description:

Patients with cirrhosis and hepatic encephalopathy refractory to conventional treatment will continue only conventional therapy with rifaximin and lactulose