Jasmohan S Bajaj, Andrew Fagan, Edith A Gavis, Travis Mousel, Mary L Gallagher, Puneet Puri, Michael Fuchs, Brian C Davis, Phillip B Hylemon, Huiping Zhou, Vishwadeep Ahluwalia, Robert Cadrain, Masoumeh Sikaroodi, Patrick M Gillevet
BACKGROUND: Minimal hepatic encephalopathy (MHE) negatively affects the prognosis of cirrhosis, but treatment is not standard. Rifamycin SV MMX (RiVM) is a nonabsorbable rifampin derivative with colonic action. METHODS: In a phase 2 placebo-controlled, double-blind randomized clinical trial patients with MHE were randomized to RiVM or placebo for 30 days with a 7-day follow-up. The primary endpoint was a change in stool cirrhosis dysbiosis ratio. Gut-brain (cognition, stool/salivary microbiome, ammonia, brain magnetic resonance spectroscopy), inflammation (stool calprotectin/serum cytokines), patient-reported outcomes (sickness impact profile: total/physical/psychosocial, high = worse), and sarcopenia (handgrip, bioelectric impedance) were secondary...
February 1, 2024: Hepatology Communications