A new milestone achieved: the first patient is recruited for the phase III trial in decompensated liver cirrhosis.
We have begun recruiting patients for LiverGut, a phase III multicentre clinical trial authorised by the AEMPS, which will evaluate the therapeutic potential of MBK-01 to slow the progression of decompensated liver cirrhosis.
The study is led by Hospital Clínic from Barcelona, under the coordination of Dr Pere Ginès, an international leader in hepatology. A total of 190 adult patients with decompensated cirrhosis, recruited from eight hospitals in Spain, will participate. The main objective is to measure the time to the first event of decompensation, such as ascites, infections, gastrointestinal bleeding or hepatic encephalopathy.
In recent years, research has revealed that intestinal dysbiosis and mucosal barrier disruption play a key role in the progression of cirrhosis. Bacterial translocation from the intestine to the liver exacerbates systemic inflammation and complications of this disease.
Decompensated cirrhosis is one of the leading causes of hospitalisation and mortality in hepatology. Currently, there is no treatment that can slow its progression. LiverGut is the first clinical trial in Europe to evaluate a microbiota-based therapy for this indication and could lay the foundations for a new therapeutic strategy in advanced hepatology.
With LiverGut, we are positioning microbiota modulation as a central axis in the treatment of complex chronic diseases, with safe, effective and sustainable solutions.
