Hepatic Encephalopathy
Conditions
Interventions
Control Group:Oral rifaximin combined with lactulose everyday
Single-dose FMT Treatment Group:Oral rifaximin combined with lactulose everyday
Take 4 oral FMT capsules per dose, twice daily, for 6 consecutive days during the first week
Two-dose FMT Treatment Group:Oral rifaximin combined with lactulose everyday
Take 4 oral FMT capsules per dose, twice daily for 6 consecutive days in the first and fifth weeks
Sponsors
Beijing You An Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, no gender restrictions; 2. Meets diagnostic criteria for liver cirrhosis (confirmed by imaging or liver biopsy); 3. At least one episode of grade 2 or higher hepatic encephalopathy (West-Haven scale >= grade 2); 4. Model for End-Stage Liver Disease (MELD) score <= 25 points; 5. Currently receiving lactulose + rifaximin therapy; 6. Patient or family member has signed an informed consent form and is able to cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Patients scheduled for liver transplantation within one month; 2. Patients with organic intestinal disease (e.g., intestinal obstruction, inflammatory bowel disease, intestinal tumours) or a history of intestinal surgery (within the last three months), or active intestinal wall injury such as severe mucosal destruction, unexplained mucosal damage, fulminant colitis, toxic megacolon or intestinal obstruction, or those receiving enteral nutrition; 3. Patients with concurrent severe systemic infections, such as systemic inflammatory response syndrome or extraintestinal organ infections, requiring broad-spectrum antibiotic intervention; those who have used broad-spectrum antibiotics (>=7 days), probiotics/prebiotics, or medications affecting the intestinal microbiota within the past 4 weeks; 4. Patients with concomitant chronic kidney disease (serum creatinine level >2.0 mg/dL) or respiratory failure; 5. Recent high-risk immunosuppressive or cytotoxic drug therapy, e.g., rituximab, doxorubicin, or sustained use of moderate-to-high-dose corticosteroids (prednisone =20mg/day) for over 4 weeks; 6. Patients with uncontrolled malignancies (excluding hepatocellular carcinoma), neurological disorders (including stroke, epilepsy, dementia, Parkinson's disease, etc.), or acute hepatic encephalopathy requiring tracheal intubation; 7. Use within the past 4 weeks of medications potentially affecting the Hepatic Encephalopathy Psychometric Evaluation Scale (PHES), such as antidepressants or sedative-hypnotics; 8. Pregnant or lactating women; 9. Participants in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of West-Haven Grade 2 or higher hepatic encephalopathy (HE) within 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of first recurrence of HE;FMT-related adverse events;PHES Score Variation;EQ-5D Score Variation;Blood Routine Test;Liver Function Test;Kidney Function Test;Coagulation Test;Blood Ammonia Test;Shannon index of a-diversity of intestinal flora;Dynamic changes in the diversity and composition of intestinal flora before and after fecal microbiota transplantation;Metabolomic changes: Variations in the contents of small-molecule metabolites such as amino acids, carbohydrates, organic acids, fatty acids, and lipids in samples including feces and blood before and after fecal microbiota transplantation; | — |
Countries
China
Contacts
Public ContactLiu xiaohui
Beijing You An Hospital, Capital Medical University
Outcome results
None listed