The impact of an oral purified microbiome therapeutic on the gastrointestinal microbiome.

ABSTRACT: VOWST (VOWST oral spores, VOS; fecal microbiota spores, live-brpk, formerly SER-109) is an FDA-approved, orally administered consortium of purified Firmicutes spores developed to prevent recurrent Clostridioides difficile infection (CDI). Although 86.7% (26/30) of patients with recurrent CDI did not experience a subsequent recurrence over 8 weeks in an open-label phase 1b study, a subsequent double-blind phase 2 study ( NCT02437487 ) did not demonstrate a significant benefit over placebo (rate of recurrence at 8 weeks in SER-109 versus placebo: 44.1% versus 53.3%). These discordant outcomes were hypothesized to be due to suboptimal dosing. This hypothesis was addressed in a pivotal phase 3 trial ( NCT03183128 ) using an approximately tenfold higher dose. In phase 3, only 12% of VOS-treated

SUBMITTER: Bryant JA 

PROVIDER: S-EPMC12823442 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature