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A Multicenter, Prospective, Randomized Controlled Study to Explore the Efficacy and Safety of Fecal microbiota Transplantation with Different Bacterial Doses in the Treatment of Recurrent Hepatic Encephalopathy

A Multicenter, Prospective, Randomized Controlled Study to Explore the Efficacy and Safety of Fecal microbiota Transplantation with Different Bacterial Doses in the Treatment of Recurrent Hepatic Encephalopathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067135
Enrollment
Unknown
Registered
2022-12-27
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic encephalopathy

Interventions

low dose of group:Intestinal bacteria transplantation, 400ml bacterial solution
high dose of group:Intestinal bacteria transplantation, 800ml bacterial solution

Sponsors

hulan (Hang zhou) Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18-75 years old (2) At least two significant episodes of hepatic encephalopathy (West Haven grade 2 and above) were associated with cirrhosis in the first 6 months and were in remission at the time of enrollment (West Haven grade 0 or 1). 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 25 or less (the score range is 6-40, and the higher the score, the more serious the condition is) (4) Meet the conditions for receiving FMT through different channels (colonoscopy, nasojejunal tube, nasogastric tube or enema) (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 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 10mg / dl [2.5umol / 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 FMT (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. Patients who cannot provide informed consent 12. Patients who are unwilling or unable to perform enema 13. Other researchers think it is not suitable to be included in this experiment

Design outcomes

Primary

MeasureTime frame
Effectiveness of FMT in the treatment of recurrent hepatic encephalopathy;

Secondary

MeasureTime frame
Adverse events related to FMT;

Countries

China

Contacts

Public ContactHainv Gao

Shulan (Hang zhou) Hospital

gaohainv@163.com13957163067

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026