Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

Last updated: September 17, 2026
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Completed

Phase

1

Condition

Arginase Deficiency

Vomiting

Hepatic Encephalopathy

Treatment

Fecal microbiota transplantation delivery through oral capsules

Fecal microbiota transplantation delivery through colonoscopy

Clinical Study ID

NCT06368895
2188
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 atadequate doses started at least 30 days before the Hepatic encephalopathy episode

Exclusion

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 ofadequate 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 orbreastfeeding)

  • Presence of known intestinal diseases

  • Any clinical condition that, in the opinion of the investigators, may contraindicatethe enrollment in the study

Study Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: Fecal microbiota transplantation delivery through oral capsules
Phase: 1
Study Start date:
April 07, 2021
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Fondazione Policlinico Agostino Gemelli IRCCS

    Rome, 00168
    Italy

    Site Not Available

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