This clinical trial is focused on studying decompensated cirrhosis, a severe stage of liver disease where the liver is significantly damaged and unable to function properly. The study will explore the use of a treatment called fecal microbiome transplantation (FMT), which involves using specially prepared capsules containing healthy bacteria from donor stool to help improve the balance of bacteria in the gut. The treatment being tested is in the form of lyophilized capsules of fecal microbiota, also known by the code name MBK-01. These capsules are taken orally, meaning they are swallowed like a pill.
The purpose of the study is to evaluate whether this treatment can help slow down the progression of decompensated cirrhosis. Participants in the study will be randomly assigned to receive either the fecal microbiome capsules or a placebo, which looks like the treatment but does not contain the active ingredients. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.
Throughout the study, participants will be monitored for any changes in their condition, including the time it takes for any new complications of cirrhosis to occur. The study will also track other health outcomes, such as survival rates and the frequency of hospital visits due to cirrhosis complications. Participants will have regular check-ups over a period of time to assess their health and the effects of the treatment. The study aims to provide valuable insights into the potential benefits of fecal microbiome transplantation for people with decompensated cirrhosis.



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