Fecal Microbiota Transplantation for Liver Failure

NCT05170971 | Recruiting

• 1 other identifier: KJ2019PJ021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Failure

Keywords

fecal microbiota transplantation; gut-liver axis; liver failure

Outcome Measures

Primary Outcomes (6)

• 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

  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

Study Arms (1)

fecal microbiota transplantation

OTHER

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

Other: fecal microbiota transplantation

Interventions

fecal microbiota transplantation OTHER

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

fecal microbiota transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Sites (1)

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

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Liver Failure

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

lanman Xu

CONTACT

+86 13587646315; 13587646315@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Infection Department

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: December 28, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (1)