Faecal Microbiota Transplantation for Liver Cirrhosis
The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function.
| Condition(s) | Liver Cirrhosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Study type | Interventional |
| Summary | The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | University of Aarhus |
| Locations | Aarhus, Denmark |
| Start date | 2021-07-01 |
| NCT ID | NCT04932577 |
| Official listing | https://clinicaltrials.gov/study/NCT04932577 |