Fecal Microbiota Transplantation for Liver Failure

Ningbo Medical Center Lihuili Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Failure

Interventions

fecal microbiota transplantationOTHER

The fecal bacteria were transplanted once every 5 days for a total of 4 times

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Pregnant or lactating women.

Locations (1)

Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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, respectively

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 %.

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, respectively

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, respectively

Observe the clinical manifestations, safety and adverse reactions of the patients

Safety and adverse events were assessed including fever, diarrhea and elevated inflammatory markers (such as C-reactive protein and procalcitonin) before and after faecal bacteria transplantation.

Central Contacts

lanman Xu

CONTACT

+86 13587646315 13587646315@163.com

Data from ClinicalTrials.gov

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