Cirrhosis
Conditions
Interventions
Standard of care group+ Conventional-Dose FMT group:Conventional-Dose FMT+Standard of care
Standard of care :Standard of care
Standard of care group + Low-Dose FMT group:Low-Dose FMT+Standard of care
Sponsors
Shenzhen Hospital of Southern Medical Unversity
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must voluntarily sign the informed consent form; 2.Diagnosis of cirrhosis: Meeting the diagnostic criteria for cirrhosis specified in the "Chinese guidelines for clinical diagnosis, treatment, and management of cirrhosis (2025)"; 3.Patients with decompensation events (e.g., ascites, variceal bleeding, hepatorenal syndrome) occurring currently or within the previous one month. 4.Age and gender: Aged 30–65 years, gender not restricted; 5.Women of child-bearing potential must agree to use effective contraception for the duration of the study and for 10 days prior and 30 days after the study; 6.Patients with CHE requires a confirmed diagnosis of non-overt HE, defined by a positive Stroop Test screen followed by a confirmatory PHES Z-score of < -4.
Exclusion criteria
Exclusion criteria: 1.Patients will be excluded if they have a diagnosis of poorly controlled psychiatric illness (e.g., schizophrenia, bipolar disorder) or any major neurological disorder that may interfere with assessment (such as, but not limited to, hypertensive encephalopathy, hypoxic-ischemic encephalopathy, alcoholic encephalopathy, Alzheimer's disease, Parkinson's disease, toxic encephalopathy, or other metabolic encephalopathies); 2.Absence of cranial imaging results within the past 6 months, or imaging findings demonstrating organic pathology that affects cognitive function, or a history of transient ischemic attack (TIA) or cranial surgery within the past 6 months; 3.Chronic alcohol consumption for more than 5 years, with an average intake exceeding 40 g/day (male) or 20 g/day (female) of ethanol calculated as pure alcohol; or a history of heavy drinking (exceeding 80 g/day of ethanol) within the past 2 weeks; 4.MELD scores > 20; 5.Patients with hepatocellular carcinoma (HCC), untreated colorectal carcinoma in situ, or any other concurrent active malignancy; 6.Patients with a history of overt hepatic encephalopathy (OHE) episodes within the past 3 months; 7.Patients who are immuno-compromised due to the following reasons: (1) HIV infection (any CD4 count);(2) inherited/primary immunodeficiency;(3) current or recent 3 months of treatment with antineoplastic agents;(4) current or recent 3 months of immunosuppressant use; 8.Presence of any other factors that may prevent the patient from independently completing the PHES and Stroop Test, such as poor vision, color blindness, or motor deficits; 9.Patients will be excluded if they have an estimated life expectancy of less than 24 months or suffer from any severe comorbidity that would limit survival or study participation, including but not limited to severe cardiac (e.g., NYHA Class III-IV), pulmonary, renal, hematologic, immunologic, urologic, or infectious diseases, or an active infection within the previous month; 10.Prior liver transplantation, TIPS, major abdominal surgery (hepatic, splenic, GI) or surgical shunt; 11.Patients who are pregnant or nursing (will be checked using a urine pregnancy test); 12.Received FMT treatment within the past 6 months; 13.History of chronic primary gastrointestinal diseases (such as inflammatory bowel disease, microscopic colitis, eosinophilic gastroenteritis, or celiac disease), severe diarrhea, or severe malnutrition; c); 14.Neutrophil count <500/mm^3 or platelet count <25,000/mm^3; 15.Deemed by the investigator as ineligible for any medical, compliance, or other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CHE patients progressed to OHE (West-Haven grade >=2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life questionnaire;Safety-related outcome;Related complications;Laboratory test results;CHE patients reversed (PHES score>-4); | — |
Countries
China
Contacts
Public ContactWang Anjiang
Shenzhen Hospital of Southern Medical Unversity
Outcome results
None listed