biostudies-literatureUnknown9(3)Bloom PP<h4>Background</h4>Novel therapies are needed to treat HE, and microbiome modulation is a promising target. VE303 is a defined consortium of 8 purified, clonal bacterial strains, known to produce metabolites that may be beneficial in HE. We evaluated the safety and efficacy of VE303 to treat HE.<h4>Methods</h4>We performed a single-center, randomized, placebo-controlled trial of VE303 in adult patients with a history of overt HE (NCT04899115). Eligible patients were taking lactulose and rifaximin, had no recent systemic antibiotics, and had MELD ≤20. All patients received 5 days of oral vancomycin followed by randomization to 14 days of VE303 or placebo (2:1). The primary endpoints were incidence of serious adverse events and change in psychometric HE score (PHES) from baseline to 4 weeks Hepatology communicationse0650https://www.ebi.ac.uk/biostudies/studies/S-EPMC11841841biostudies-literatureSafety and efficacy of a defined bacterial consortium, VE303, to treat HE.PMC11841841Silber JLCrossette EYoung VBNorman JMLok ASFBloom PPBassis CMfalseSafety and efficacy of a defined bacterial consortium, VE303, to treat HE.<h4>Background</h4>Novel therapies are needed to treat HE, and microbiome modulation is a promising target. VE303 is a defined consortium of 8 purified, clonal bacterial strains, known to produce metabolites that may be beneficial in HE. We evaluated the safety and efficacy of VE303 to treat HE.<h4>Methods</h4>We performed a single-center, randomized, placebo-controlled trial of VE303 in adult patients with a history of overt HE (NCT04899115). Eligible patients were taking lactulose and rifaximin, had no recent systemic antibiotics, and had MELD ≤20. All patients received 5 days of oral vancomycin followed by randomization to 14 days of VE303 or placebo (2:1). The primary endpoints were incidence of serious adverse events and change in psychometric HE score (PHES) from baseline to 4 weeks 2025-01-01T00:00:00Z2025 Mar2026-06-06T23:32:23.914Z2026-06-06T03:10:55.497ZS-EPMC118418413996942810.1097/HC9.0000000000000650