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VE303 for Prevention of Recurrent Clostridioides Difficile Infection

NCT06237452 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 852

Last updated 2026-05-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Vedanta Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2027-06-30
Completion
2027-10-31
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237452 on ClinicalTrials.gov