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Active Not Recruiting NCT05669651

Explore the Efficacy and Safety of FMT With Different Bacterial Doses in the Treatment of Hepatic Encephalopathy

Conditions: Hepatic Encephalopathy

Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 100
Sponsor: Pengfei Zou

Location: China

Summary

Hepatic encephalopathy (HE) is one of the most serious complications of end-stage liver disease and an independent predictor of death in patients with liver cirrhosis. Recurrent hepatic encephalopathy is defined as recurrent hepatic encephalopathy after rifaximin combined with lactulose treatment. This project designs a prospective, multicenter cohort study on the treatment of recurrent hepatic encephalopathy with fecal microbiota transplantation, carries out the comparison of fecal microbiota transplantation with different amounts of bacteria, and the dynamic sequencing of the macro genome of the recipient's stool, compares the effectiveness and safety of fecal microbiota transplantation with different amounts of bacteria in the treatment of recurrent hepatic encephalopathy, and explores the internal mechanism of different effects, providing a new idea for the treatment of recurrent HE in clinical practice.

Eligibility Criteria

Inclusion Criteria:18-75 years old;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;MELD score i ≤ 25 points (score range is 6-40, the higher the score is, the more serious the disease is)Meet the requirements for receiving FMT through nasojejunal tubeThe subject (or guardian) has signed the informed consent formExclusion Criteria:Patients expected to undergo liver transplantation within 1 monthPatients with known causes of hepatic encephalopathy (including gastrointestinal bleeding and placement of portal systemic shunt or transjugular intrahepatic portal systemic shunt) within 3 monthsThere 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) complicated with infection, or active and spontaneous bacterial peritonitisHeavy drinking in recent 12 weeksHave used drugs that affect the psychometric score of hepatic encephalopathy (PHEs), such as antidepressants and sedative hypnosis, in recent 4 weeksPatients who are allergic to antibiotics before treatmentInfection during FMT (diagnosis by positive blood culture, urinalysis and puncture)Patients with chronic endogenous gastrointestinal diseases, such as inflammatory bowel disease (ulcerative colitis, Crohn's disease or microscopic colitis), irritable bowel syndromeSuffering from neurological diseases, such as stroke, epilepsy, dementia and Parkinson's diseasePregnant or lactating patients (urine pregnancy test will be used for examination)Patients who cannot provide informed consentPatients who are unwilling or unable to perform enemaOther researchers think it is not suitable to be included in this experiment

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05669651). StuddyBuddy aggregates publicly available trial information.