Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-24 @ 1:29 PM
NCT ID:
NCT06368895
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06368895
Study Brief:
Protocol Section:
NCT06368895