Oral capsule fecal microbiota transplantation for treating hepatic encephalopathy
Efficacy and Safety of Fecal Microbiota Transplantation by Oral Capsules in Patients With Liver
This study is testing whether taking fecal microbiota capsules can help people with liver disease and brain problems feel better when other treatments aren't working.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06368895 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) delivered through oral capsules for patients with hepatic encephalopathy that does not respond to standard treatments like rifaximin and lactulose. Participants with liver cirrhosis will be randomized into three groups: one receiving FMT via colonoscopy and oral capsules, another receiving only oral capsules, and a control group continuing conventional therapy. The study aims to assess changes in gut microbiota composition and inflammation, correlating these changes with clinical improvements in patients.
Who should consider this trial
Good fit: Ideal candidates include patients with liver cirrhosis and hepatic encephalopathy grade >1 who have not responded to conventional therapies.
Not a fit: Patients with contraindications to fecal microbiota transplantation or other causes of encephalopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from refractory hepatic encephalopathy.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other conditions, this specific approach for hepatic encephalopathy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome
- Fondazione Policlinico Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.