Microbiota Transplant Therapy for Hepatic Encephalopathy

(MASTERPIECE Trial)

This trial aims to determine if capsules filled with healthy microbes can prevent brain-related problems in Veterans with liver disease and hepatic encephalopathy, a condition affecting the brain due to liver issues. Participants will receive either the microbiota transplant therapy (MTT) capsules or a placebo, which resembles a sugar pill with no active treatment. Ideal candidates for this trial include those diagnosed with cirrhosis (a serious liver disease) who have experienced episodes of hepatic encephalopathy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

The trial does not specify if you need to stop taking your current medications, but it mentions that participants can be on stable doses of lactulose and/or rifaximin for 4 weeks before joining. It's best to discuss your specific medications with the trial team.

Previous studies have shown that microbiota transplant therapy (MTT) capsules are safe for people with cirrhosis and hepatic encephalopathy, a brain condition caused by liver problems. No significant side effects were reported, regardless of the dose, administration method, or donor type, suggesting that the treatment is generally well-tolerated. Additionally, another study found that oral fecal microbiota capsules were well-tolerated by patients with cirrhosis, indicating that participants did not experience significant negative side effects. Current research supports the treatment's safety.¹²³⁴⁵

Unlike other treatments for hepatic encephalopathy, which typically involve medications like lactulose and rifaximin, microbiota transplant therapy (MTT) is unique because it uses live bacteria to restore balance in the gut. Most traditional treatments focus on reducing ammonia levels in the blood, but MTT targets the gut microbiome, aiming to enhance its health and function. Researchers are excited about this approach because it offers a novel way to potentially improve brain function by directly addressing the root cause of the imbalance in gut bacteria. Plus, the MTT capsules provide a non-invasive delivery method, which could mean fewer side effects and a more patient-friendly option.

Research has shown that microbiota transplant therapy (MTT), which participants in this trial may receive, can help treat hepatic encephalopathy (HE), a brain condition caused by liver issues. Studies have found that MTT works better than the antibiotic rifaximin at lowering ammonia levels, which are often high in people with HE, and at improving mental function. A similar treatment, fecal microbiota transplantation, reduced the chances of HE recurrence without adding significant risks. Patients receiving this treatment experienced better brain function and changes in gut bacteria that may help prevent future HE episodes. Overall, MTT has shown promising results in improving HE symptoms and preventing their return.²³⁵⁶⁷