Fecal microbiota transplantation for patients with liver failure
The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure
This study tests whether a treatment using healthy gut bacteria can help people with liver failure feel better and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ningbo Medical Center Lihuili Hospital Government |
| Locations | 1 site (Ningbo, Zhejiang) |
| Trial ID | NCT05170971 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and therapeutic effects of fecal microbiota transplantation in patients suffering from liver failure. It aims to assess how this intervention affects the intestinal microecology and the gut-liver axis immune system. The study will include patients aged 18-65 who meet specific diagnostic criteria for liver failure and will monitor for adverse reactions and overall treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with acute liver failure due to chronic liver disease and associated complications.
Not a fit: Patients with severe comorbid conditions such as heart failure, COPD, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve liver function and overall health outcomes for patients with liver failure.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other conditions, its application in liver failure is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ningbo, Zhejiang
- Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: lanman Xu
- Email: 13587646315@163.com
- Phone: +86 13587646315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.