Actively Recruiting
The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure
Led by Ningbo Medical Center Lihuili Hospital · Updated on 2024-03-12
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety, side effects, and potential benefits of fecal microbiota transplantation in patients with liver failure. The study also aims to understand how this treatment affects the gut bacteria and the connection between the gut and liver immune system. The research intends to optimize fecal microbiota transplantation techniques to improve treatment outcomes for liver failure patients. Participants receive fecal microbiota transplantation every 5 days, with a total of four treatments given. This intervention involves transplanting healthy fecal bacteria to the patient's intestines to study its effects on liver failure. The treatment schedule is fixed, with follow-up visits planned to monitor changes over time. During the study, participants will have blood and fecal samples collected before the first transplantation and at several points after treatment: at 5, 10, 15, and 20 days, as well as 4 and 8 weeks later. These samples will help track liver and coagulation function, gut microbiota changes, immune system markers, and clinical symptoms. The study also observes safety and any adverse reactions throughout the follow-up period, providing a comprehensive view of the treatment's effects over approximately two months.
CONDITIONS
Brief Title
Fecal Microbiota Transplantation for Liver Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to sign informed consent
- Patients aged 18 to 65 years
- Diagnosed with liver failure based on 2018 liver failure diagnosis and treatment guidelines, including acute worsening of jaundice and coagulation dysfunction on chronic liver disease
- May have complications such as hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, and extrahepatic organ failure
- Serum total bilirubin (TBIL) ≥ 10 times the upper limit of normal or daily increase ≥ 17.1 μmol/L
- Presence of bleeding with prothrombin activity (PTA) ≤ 40% or international normalized ratio (INR) ≥ 1.5
You will not qualify if you...
- Patients with severe heart failure, chronic obstructive pulmonary disease (COPD), stroke, nephrotic syndrome, or similar severe conditions
- Patients with gastrointestinal bleeding, lung infection, septicemia, or similar infections
- Patients diagnosed with liver cancer, lung cancer, lymphoma, or other malignant tumors
- Patients taking anticoagulants or with long-term mental or immune diseases
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 days
Participants receive fecal microbiota transplantation once every 5 days for a total of 4 times.
4 treatment visits (in-person) every 5 days
Duration - Up to 8 weeks after treatment
Participants are followed up to monitor liver function, coagulation function, clinical manifestations, safety, and changes in gut microbiota and proinflammatory cytokines.
6 follow-up visits at 5, 10, 15, 20 days, 4 weeks, and 8 weeks after treatment
Trial Site Locations
Total: 1 location
1
Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
L
lanman Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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