This clinical trial is focused on studying the effects of a treatment for patients with cirrhosis and ascites. Cirrhosis is a condition where the liver becomes severely scarred, and ascites is the buildup of fluid in the abdomen, often occurring in people with liver disease. The treatment being tested is called INTESTIFIX 001, which is an encapsulated fecal microbiota transfer, meaning it involves transferring beneficial bacteria from healthy stool into the patient’s gut. This study will also use a placebo, which is a substance with no active medication, to compare the effects of the treatment.
The purpose of this study is to evaluate the safety of these FMT capsules in treating immune activation in patients with cirrhosis and ascites. Participants will take the treatment or placebo orally in capsule form. The study will last for about three months, during which participants will have regular check-ups to monitor their health and any side effects. The study aims to see if the treatment can help reduce inflammation and improve liver function and quality of life.
Throughout the study, researchers will observe any serious adverse events and other side effects. They will also measure changes in inflammation markers, liver function scores, and quality of life assessments. The goal is to determine if the treatment is safe and potentially beneficial for patients with these liver conditions. Participants will be closely monitored to ensure their safety and well-being during the trial.



Germany