Fecal Microbiota Transplantation for Liver Failure

Liver Failure Clinical Trial

Official title:

The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170971
• Other study ID #: KJ2019PJ021
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Ningbo Medical Center Lihuili Hospital
• Contact: lanman Xu
• Phone: +86 13587646315
• Email: 13587646315[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

Other:
• fecal microbiota transplantation
The fecal bacteria were transplanted once every 5 days for a total of 4 times

Locations

Country	Name	City	State
China	Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo Medical Center Lihuili Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	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
Primary	proinflammatory cytokine change	IL-17,IL-6,TNF-a, TGF-ß, IFN-? 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