Using fecal microbiota transplantation to treat liver cirrhosis
Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
This study is testing if a treatment called fecal microbiota transplantation can help people with liver cirrhosis feel better and reduce complications.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT04932577 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of fecal microbiota transplantation (FMT) on patients with liver cirrhosis, particularly focusing on complications, disease progression, and mortality. The study will randomly assign 220 patients experiencing acute decompensation of liver cirrhosis into two groups: one receiving FMT and the other receiving a placebo. Researchers will monitor the patients for one year to assess changes in gut microbiota, gut barrier function, systemic inflammation, and immune response, aiming to understand the mechanistic effects of FMT on liver disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with liver cirrhosis and acute decompensation requiring intervention.
Not a fit: Patients with multiple organ failures, untreated malignancies, or certain infections and diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the prognosis and quality of life for patients with liver cirrhosis.
How similar studies have performed: Previous studies have shown promising results with fecal microbiota transplantation in various conditions, suggesting potential success in this novel application for liver cirrhosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years * Liver cirrhosis with Child-Pugh ≤ 12 * Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, infections leading to progressive liver failure, overthepatic encephalopathy, alcoholic hepatitis) Exclusion Criteria: * More than one organ failure defined by CLIF-SOFA score * Untreated malignancy apart from non-melanoma skin cancer * Untreated viral hepatitis * HIV * Inflammatory bowel disease * Celiac disease * Clostridioides Difficile infection * Pregnancy * Unable to participate based on medical judgement
Where this trial is running
Aarhus
- Department of Hepatology and Gastroenterology, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Karen Louise Thomsen, PhD
- Email: karethom@rm.dk
- Phone: +4526949260
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.