Fecal Microbiota Transplantation for Liver Failure
ConditionLiver Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNingbo Medical Center Lihuili Hospital
About this trial
To investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and "gut-liver axis immune system" of liver failure, and further optimization of fecal microbiota transplantation technology.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients willing to sign informed consent
Patients aged 18-65
According to the diagnosis standard of liver failure in the guide for diagnosis and treatment of liver failure (2018 Edition), the eligible patients are included, that is, on the basis of chronic liver disease, the syndrome with acute jaundice deepening and coagulation dysfunction as the manifestation of liver failure caused by various inducements can be combined with complications such as Hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, etc And extrahepatic organ failure. The patient's jaundice deepened rapidly, the serum TBIL ≥ 10 × ULN or the daily rise ≥ 17.1 μ mol / L; there was bleeding, PTA ≤ 40% (or INR ≥ 1.5)
Disqualifiers
Patients with severe heart failure, COPD, cerebrovascular accident, nephrotic syndrome, etc;
Patients with gastrointestinal bleeding, pulmonary infection, septicemia, etc
Patients with liver cancer, lung cancer, lymphoma and other malignant tumors
Patients taking anticoagulants, mental diseases and immune diseases for a long time
Trial design
Design model
Single group
Treatments tested in this trial
fecal microbiota transplantation
Other interventionThe fecal bacteria were transplanted once every 5 days for a total of 4 times
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: fecal microbiota transplantationOther 1 intervention
Trial outcomes
Primary outcomes
1
Liver function change
The investigators need to monitor the changes in liver and kidney function before and after faecal bacteria transplantation，such as ALT、AST、GGT 、TBIL(The units of these indices are U/L).
Time frame
Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively2
Coagulation function change
Prothrombin activity are one of the indexes to evaluate the degree of liver failure in patients.The units of this indices is %.
Time frame
Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively3
Model for end-stage liver disease score change
The model for end-stage liver disease (MELD) score is a prospectively developed and validated scale for the severity of end-stage liver disease.The higher the MELD score, the more severe the liver disease and the greater the risk of death. The fatality rate of patients with MELD between 20 and 30 was more than 30%, that of patients with MELD between 30 and 40 was more than 50%, and that of patients with MELD \>40 was more than 70%.
Time frame
Model for end-stage liver disease score were obtained separately in 1 week before faecal bacteria transplantation, and to access once again at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively4
gut microbiota change
Gene sequencing and metabonomics analysis of fecal flora.
Time frame
Fecal samples were collected 1 week before faecal bacteria transplantation, and change from at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectivelySponsors and contacts
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Source ClinicalTrials.gov