Using fecal microbiota transplantation to treat liver cirrhosis
Official title: Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
Run by University of Aarhus · NCT04932577 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | July 1, 2021 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2027 |
| Registry record updated | January 24, 2025 |
| Trial ID | NCT04932577 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with liver cirrhosis and acute decompensation requiring intervention.
✕Probably not a fit
Patients with multiple organ failures, untreated malignancies, or certain infections and diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with fecal microbiota transplantation in various conditions, suggesting potential success in this novel application for liver cirrhosis.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.