Status: Recruiting
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
Participants needed: 852
Trial details
Phase: Phase 3Age: 12+Biological sex: AllType: InterventionalSponsor: Vedanta Biosciences, Inc.Updated: Jun 2, 2026Locations: 215
Eligibility criteria
Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a labora... [+15]
History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at... [+7]