Back to resultsFecal Microbiota Transplantation for Liver Failure
Primary Purpose
Liver Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fecal microbiota transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Liver Failure focused on measuring fecal microbiota transplantation, gut-liver axis, liver failure
Eligibility Criteria
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.
Sites / Locations
- Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
fecal microbiota transplantation
Arm Description
The fecal bacteria were transplanted once every 5 days for a total of 4 times.
Outcomes
Primary Outcome Measures
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).
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%.
gut microbiota change
Gene sequencing and metabonomics analysis of fecal flora.
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05170971
First Posted
May 27, 2021
Last Updated
December 9, 2021
Sponsor
Ningbo Medical Center Lihuili Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05170971
Brief Title
Fecal Microbiota Transplantation for Liver Failure
Official Title
The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ningbo Medical Center Lihuili Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
Keywords
fecal microbiota transplantation, gut-liver axis, liver failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fecal microbiota transplantation
Arm Type
Other
Arm Description
The fecal bacteria were transplanted once every 5 days for a total of 4 times.
Intervention Type
Other
Intervention Name(s)
fecal microbiota transplantation
Intervention Description
The fecal bacteria were transplanted once every 5 days for a total of 4 times
Primary Outcome Measure Information:
Title
Liver function change
Description
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
Title
Coagulation function change
Description
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, respectively
Title
Model for end-stage liver disease score change
Description
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
Title
gut microbiota change
Description
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
Title
Observe the clinical manifestations, safety and adverse reactions of the patients
Description
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.
Time Frame
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
Title
proinflammatory cytokine change
Description
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).
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lanman Xu
Phone
+86 13587646315
Email
13587646315@163.com
Facility Information:
Facility Name
Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu lanman
Phone
+86 13587646315
Email
13587646315@163.com
12. IPD Sharing Statement
Learn more about this trial
Fecal Microbiota Transplantation for Liver Failure
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