An interventional study of Fecal Microbiota Transplantation in Hepatic Encephalopathy, sponsored by Hainv Gao. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by Hainv Gao · Not applicable, Interventional, and Treatment
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.
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.
218 studies on the registry are indexed under Hepatic Encephalopathy; 48 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 148 interventional studies indexed under Hepatic Encephalopathy.
Browse Hepatic Encephalopathy studies →This is the only study on the registry with Hainv Gao as lead sponsor.
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Exclusion Criteria:
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.
Other: Fecal Microbiota Transplantation
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 .
Other: 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.
Incidence of the first breakthrough episode of hepatic encephalopathy after FMT.
West-Haven Grade ≥2 that occurs within 12 weeks is defined as the first breakthrough episode of hepatic encephalopathy after FMT. Breakthrough attack patients identified as FMT is invalid, no breakthrough attack patients identified as FMT is effective, at the same time compare the advantages and disadvantages of two ways of FMT efficacy.
Time frame: 12 weeks
FMT related serious adverse events
FMT related serious adverse events
Time frame: one month
FMT related adverse events
FMT related adverse events
Time frame: one month
Plan to share: No
This study is active, not recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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