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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fecal microbiota transplantation | Other | The fecal bacteria were transplanted once every 5 days for a total of 4 times. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fecal microbiota transplantation | Other | The fecal bacteria were transplanted once every 5 days for a total of 4 times |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 %. | 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 |
| 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%. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lanman Xu | Contact | +86 13587646315 | 13587646315@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | China |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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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. |
| These indicators 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 |
| proinflammatory cytokine change | IL-17,IL-6,TNF-α, TGF-β, IFN-γ and other cytokines were detected by ELISA(The units of these indices are pg/mL). | 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 |