Clinical trial NCT05170971: 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
Overall status: RECRUITING
Phase: NA
Conditions: Liver Failure
Keywords: fecal microbiota transplantation
gut-liver axis
liver failure
Lead sponsor: Ningbo Medical Center Lihuili Hospital
Sponsor class: OTHER_GOV
First posted: 2021-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Liver function change
timeFrame: 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
measure: Coagulation function change
timeFrame: 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
measure: Model for end-stage liver disease score change
timeFrame: 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
measure: gut microbiota change
timeFrame: 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
measure: Observe the clinical manifestations, safety and adverse reactions of the patients
timeFrame: 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
measure: proinflammatory cytokine change
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University
state: Zhejiang
Study officials:
References: