Hepatic encephalopathy
Conditions
Interventions
High-frequency dosing group:Intervention:Oral encapsulated fecal microbiota transplantation,96 capsules per dose
Intervention Time:Baseline and post-cFMT (week 4)
Low-frequency dosing group:Intervention:Oral encapsulated fecal microbiota transplantation,96 capsules per dose
InterventionTime:Baseline and post-cFMT (week 12)
Sponsors
hulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years; 2.Hepatic encephalopathy episodes (West Haven grade 2 or above) that occurred following rifaximin treatment were associated with cirrhosis within the preceding 6 months, and were in remission (West Haven grade 0 or 1) at the time of enrollment.The onset of hepatic encephalopathy caused by gastrointestinal bleeding requiring at least 2 units of blood transfusion, sedative use, renal failure requiring dialysis or central nervous system injury is not recorded as the previous onset; 3.End stage liver disease (MELD) score is 22 or less (the score range is 6-40, and the higher the score, the more serious the condition is); 4.Able to take oral capsule medication; 5.The subject (or guardian) has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients expected to undergo liver transplantation within 1 month; 2. Patients with known causes of hepatic encephalopathy (including gastrointestinal bleeding) within 3 months; 3. There are chronic renal insufficiency (creatinine level > 2.0 mg/dl), respiratory insufficiency, anemia (HB 10 mg/dl [2.5 umol/L]; or serum potassium < 2.5 mmol/L) complicated with infection, or active and spontaneous bacterial peritonitis; 4. Heavy drinking in recent 12 weeks; 5. Have used drugs that affect the psychometric score of hepatic encephalopathy (PHEs), such as antidepressants and sedative hypnosis, in recent 4 weeks; 6. Patients who are allergic to antibiotics before treatment; 7. Infection during cFMT (diagnosis by positive blood culture, urinalysis and puncture); 8. Patients with chronic endogenous gastrointestinal diseases, such as inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis), irritable bowel syndrome; 9. Suffering from neurological diseases, such as stroke, epilepsy, dementia and Parkinson's disease; 10. Pregnant or lactating patients (urine pregnancy test will be used for examination); 11.Uncontrolled hepatic or other systemic malignancies; 12.Patients with dysphagia or intestinal obstruction precluding oral capsule intake; 13.Other researchers think it is not suitable to be included in this experiment; 14. Patients who cannot provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of cFMT in the treatment of hepatic encephalopathy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events related to FMT; | — |
Countries
China
Contacts
Public ContactHainv Gao
Shulan (Hangzhou) Hospital
Outcome results
None listed