Explore the Efficacy and Safety of FMT With Different Bacterial Doses in the Treatment of Hepatic Encephalopathy
NCT ID: NCT05669651
Last Updated: 2023-03-24
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2022-12-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low dose of group
Complete the fecal bacteria transplantation through the upper digestive tract:
1. Intestinal preparation: Amoxicillin 0.5g bid, metronidazole 0.4g bid and levofloxacin 0.5g qd for 3 days.
2. FMT: After 12h of antibiotic discontinuation, the total amount of bacterial liquid was 400ml, 100ml each time, Q12h, 2 days after 12h of antibiotic discontinuation.
Fecal Microbiota Transplantation
Fecal microbiota transplantation (FMT) refers to the transplantation of functional flora from healthy people's feces into patients' intestines to rebuild new intestinal flora and achieve the treatment of intestinal and parenteral diseases. In this study, 100 patients with recurrent hepatic encephalopathy were randomly divided into 1:1 groups to receive FMT with different amounts of bacteria, observe the therapeutic effect and adverse reactions of hepatic encephalopathy, and evaluate the effectiveness and safety of the two groups of patients. At the same time, the blood and stool samples of patients with recurrent hepatic encephalopathy before and after FMT were collected clinically, the composition of bile acid and other metabolites in stool and serum samples was analyzed, and the effective core flora was identified to clarify the mechanism of intestinal bacteria transplantation for the treatment of recurrent hepatic encephalopathy.
High dose of group
Complete the fecal bacteria transplantation through the upper digestive tract:
1. Intestinal preparation: Amoxicillin 0.5g bid, metronidazole 0.4g bid and levofloxacin 0.5g qd for 3 days.
2. FMT: After 12h of antibiotic discontinuation, the total amount of bacterial liquid was 800ml, 100ml each time, Q12h, 4 days .
Fecal Microbiota Transplantation
Fecal microbiota transplantation (FMT) refers to the transplantation of functional flora from healthy people's feces into patients' intestines to rebuild new intestinal flora and achieve the treatment of intestinal and parenteral diseases. In this study, 100 patients with recurrent hepatic encephalopathy were randomly divided into 1:1 groups to receive FMT with different amounts of bacteria, observe the therapeutic effect and adverse reactions of hepatic encephalopathy, and evaluate the effectiveness and safety of the two groups of patients. At the same time, the blood and stool samples of patients with recurrent hepatic encephalopathy before and after FMT were collected clinically, the composition of bile acid and other metabolites in stool and serum samples was analyzed, and the effective core flora was identified to clarify the mechanism of intestinal bacteria transplantation for the treatment of recurrent hepatic encephalopathy.
Interventions
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Fecal Microbiota Transplantation
Fecal microbiota transplantation (FMT) refers to the transplantation of functional flora from healthy people's feces into patients' intestines to rebuild new intestinal flora and achieve the treatment of intestinal and parenteral diseases. In this study, 100 patients with recurrent hepatic encephalopathy were randomly divided into 1:1 groups to receive FMT with different amounts of bacteria, observe the therapeutic effect and adverse reactions of hepatic encephalopathy, and evaluate the effectiveness and safety of the two groups of patients. At the same time, the blood and stool samples of patients with recurrent hepatic encephalopathy before and after FMT were collected clinically, the composition of bile acid and other metabolites in stool and serum samples was analyzed, and the effective core flora was identified to clarify the mechanism of intestinal bacteria transplantation for the treatment of recurrent hepatic encephalopathy.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Hainv Gao
OTHER
Responsible Party
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Hainv Gao
professor
Principal Investigators
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Hainv Gao, doctor
Role: STUDY_CHAIR
Shulan (Hangzhou) Hospital
Locations
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Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China
Countries
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References
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Bajaj JS, O'Leary JG, Tandon P, Wong F, Garcia-Tsao G, Kamath PS, Maliakkal B, Biggins SW, Thuluvath PJ, Fallon MB, Subramanian RM, Vargas HE, Lai J, Thacker LR, Reddy KR. Hepatic Encephalopathy Is Associated With Mortality in Patients With Cirrhosis Independent of Other Extrahepatic Organ Failures. Clin Gastroenterol Hepatol. 2017 Apr;15(4):565-574.e4. doi: 10.1016/j.cgh.2016.09.157. Epub 2016 Oct 5.
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Zou P, Bi Y, Tong Z, Wu T, Li Q, Wang K, Fan Y, Zhao D, Wang X, Shao H, Huang H, Ma S, Qian Y, Zhang G, Liu X, Jin Q, Ru Q, Qian Z, Sun W, Chen Q, You L, Wang F, Zhang X, Qiu Z, Lin Q, Lv J, Zhang Y, Geng J, Mao R, Liu J, Zheng Y, Ding F, Wang H, Gao H. Comparisons of efficacy and safety of 400 or 800 ml bacterial count fecal microbiota transplantation in the treatment of recurrent hepatic encephalopathy: a multicenter prospective randomized controlled trial in China. Trials. 2024 Nov 27;25(1):799. doi: 10.1186/s13063-024-08578-9.
Other Identifiers
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Shulan (Hang zhou)2
Identifier Type: -
Identifier Source: org_study_id
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