Bilbao, July 29, 2025.
Biotech company Mikrobiomik has officially begun patient recruitment for LiverGut, a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial authorized by the Spanish Agency of Medicines and Medical Devices (AEMPS). The study will evaluate the therapeutic potential of MBK-01, its oral microbiota-based therapy, in slowing the progression of decompensated liver cirrhosis.
The trial is led by Hospital Clínic of Barcelona, under the coordination of Dr. Pere Ginès, a world-renowned expert in hepatology. A total of 190 adult patients with decompensated cirrhosis will be enrolled across eight hospitals in Spain. The primary endpoint is time to first decompensation event, such as ascites, infection, gastrointestinal bleeding, or hepatic encephalopathy.
Recent research has shown that intestinal dysbiosis and impaired mucosal barrier function play a critical role in the progression of cirrhosis. Bacterial translocation from the gut to the liver contributes to systemic inflammation and worsening clinical complications.
MBK-01, developed by Mikrobiomik, aims to restore functional intestinal microbiota through a purified, standardized, and non-invasive oral formulation. The goal is to reinforce the gut barrier, modulate hepatic immunity, and slow the clinical deterioration associated with advanced cirrhosis.
Decompensated cirrhosis is one of the leading causes of hospitalization and mortality in hepatology. Currently, no approved therapy has demonstrated the ability to effectively slow its progression. LiverGut is the first clinical trial in Europe to evaluate a microbiota-based treatment in this indication and may pave the way for a new therapeutic paradigm in advanced liver disease.
This study expands Mikrobiomik’s clinical program, which already includes a completed Phase III trial in Clostridioides difficile infection and an ongoing Phase II trial (DIREBIOT) in recurrent acute diverticulitis. With LiverGut, the company reinforces its commitment to microbiota modulation as a central therapeutic strategy for complex chronic diseases—offering safe, effective, and scalable solutions.
