NCT03788434 - CONSORTIUM - VE303 & Clostridioides difficile infection (CDI) (recurrent)

Background

Donor-derived fecal microbiota treatments are effective in preventing recurrent Clostridioides difficile infection (rCDI). These treatments have variable quality attributes:

• They are difficult to scale.


• There is a risk of pathogen transfer with these treatments.
  VE303 is a defined consortium of eight purified, clonal bacterial strains and is developed for the prevention of rCDI (2).

Study overview

It is a randomized, quadruple-blinded, placebo-controlled phase II prevention trial (parallel assignment) evaluating VE303 (high-dose vs low-dose vs placebo) in 79 enrolled (actual) patients with primary CDI with high-risk for recurrence population.

Primary outcome measures

CDI Recurrence Rate at Week 8

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