NCT06237452

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 852 (estimated)
• Sponsor: Vedanta Biosciences, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Clostridium Difficile
• Clostridium Difficile Infections
• Clostridium Difficile Infection Recurrence
• Clostridioides Difficile Infection
• Clostridioides Difficile Infection Recurrence
• CDI
• C. Diff Infection
• Recurrent Clostridium Difficile Infection
• C.Difficile Diarrhea
• Diarrhea Infectious

Interventions

Type	Name	Description
BIOLOGICAL	VE303	VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions.
BIOLOGICAL	Placebo	Placebo capsules contain microcrystalline cellulose. Placebo capsules are visually identical to and not discernible from VE303 capsules. Placebo capsules will not contain any VE303 drug product.

Timeline

• Start date: 2024-05-20
• Primary completion: 2027-06-01
• Completion: 2027-10-01
• First posted: 2024-02-01
• Last updated: 2026-04-07

Locations

214 sites across 24 countries: United States, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study