Mafra

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, for preventing recurrence of Clostridioides difficile infection CDI. This Phase 3, randomized, double-blind, placebo-controlled trial aims to assess the safety and rate of CDI recurrence eight weeks after treatment. The study includes participants with either recurrent CDI or primary CDI at high risk of recurrence, comparing VE303 to a placebo. Participants receive either VE303 or placebo capsules three times daily for 14 days, following 10 to 21 days of standard antibiotic treatment for CDI. VE303 capsules contain the active live bacteria, while placebo capsules contain inactive ingredients and look identical. The study is divided into two stages focusing on recurrent CDI and high-risk primary CDI populations. During the trial, participants are monitored for CDI recurrence over eight weeks, with assessments including stool sample testing and symptom tracking. The study evaluates the effectiveness of VE303 in preventing CDI from returning after initial antibiotic treatment, while monitoring participant safety. Total participation time includes the treatment period plus follow-up to week 8.