VA Office of Research and Development
The goal of this clinical trial is to find out whether changing the microbes in the bowels of Veterans with cirrhosis and hepatic encephalopathy (a condition that affects the brain as a result of liver problems) using capsules made from microbes from healthy people can prevent future episodes of hepatic encephalopathy.
Wartime injuries as well as metabolic disorders can result in liver injury directly or indirectly through PTSD, metabolic disorders, and/or alcohol misuse. These liver injuries culminate in cirrhosis, which affects 4.9 million patients in the US, \>80,000 of whom are Veterans. Moreover, numerous Veterans with cirrhosis remain undiagnosed, suggesting these numbers are an underestimation. A major complication of cirrhosis, which is exacerbated by alcohol misuse and PTSD, is hepatic encephalopathy (HE), which affects \>50% of Veterans with cirrhosis. Current HE therapies are lactulose (inexpensiv…
Inclusion Criteria: * 21 years of age * Cirrhosis diagnosed by any of the following in a patient with chronic liver disease * Liver Biopsy * Radiologic evidence of varices, cirrhosis or portal hypertension * Laboratory evidence of platelet count \<110,000 or AST/ALT ratio\>1 * Endoscopic evidence of varices or portal hypertensive gastropathy * Prior overt HE (patient can be on lactulose and/or rifaximin 4 weeks stable dosing) * Able to give written, informed consent \[mini-mental status exam (MMSE)\]\>25 at the time of consenting) * For lactulose only group: Prior HE…
MTP-101-C is manufactured using cGMP protocols in the Molecular and Cellular Therapeutics (MCT) facility at the University of Minnesota.
Placebo capsule
Arctuva estimate
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