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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05669651
Eligibility Criteria:
Inclusion Criteria:
1. 18-75 years old;
2. At least two obvious episodes of hepatic encephalopathy (West-Haven ≥ 2 ) were related to cirrhosis in the first 6 months, and the condition was in remission (West Haven grade 0 or 1) at the time of enrollment. The attack of hepatic encephalopathy caused by gastrointestinal bleeding requiring at least 2 units of blood transfusion, the use of sedatives, renal failure requiring dialysis or central nervous system injury is not recorded as the previous attack;
3. MELD score i ≤ 25 points (score range is 6-40, the higher the score is, the more serious the disease is)
4. Meet the requirements for receiving FMT through nasojejunal tube
5. The subject (or guardian) has signed the informed consent form
Exclusion Criteria:
1. Patients expected to undergo liver transplantation within 1 month
2. Patients with known causes of hepatic encephalopathy (including gastrointestinal bleeding and placement of portal systemic shunt or transjugular intrahepatic portal systemic shunt) within 3 months
3. There are chronic renal insufficiency (creatinine level \> 2.0mg/dl), respiratory insufficiency, anemia (HB \< 8g / dl), electrolyte abnormalities (serum sodium \< 125umol / L; serum calcium \> 10mg / dl \[2.5umol / l\]; or serum potassium \< 2.5 mmol / L)
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 (pathogen obtained through sterile sites)
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. Patients who cannot provide informed consent
12. Patients who are unwilling or unable to undergo indwelling nasojejunal tube
13. Other researchers think it is not suitable to be included in this experiment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05669651
Study Brief:
Protocol Section:
NCT05669651