VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Phase 3

Recruiting

• Conditions: Clostridioides Difficile Infection Recurrence; Diarrhea Infectious; Clostridium Difficile; Clostridium Difficile Infection Recurrence; C.Difficile Diarrhea; Clostridioides Difficile Infection; Clostridium Difficile Infections; C. Diff Infection; Recurrent Clostridium Difficile Infection; CDI
• Interventions: Biological: Placebo; Biological: VE303

• Registration Number: NCT06237452
• Lead Sponsor: Vedanta Biosciences, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Study Start: 2024-05-20
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-18
• Last Update Posted: 2025-09-23
• Primary Completion: 2027-06
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 852

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
VE303	VE303	Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.

Primary Outcome Measures

Name	Time	Method
CDI Recurrence Rate at Week 8	8 weeks	Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.

Trial Locations

Locations (190)

Advanced Gastroenterology, P.C.; 🇺🇸 Chandler, Arizona, United States

Om Research, LLC; 🇺🇸 Apple Valley, California, United States

Science 37 Inc (Remote/Home option); 🇺🇸 Culver City, California, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

North America Research Institute; 🇺🇸 San Dimas, California, United States

Clinical Trials Management Services; 🇺🇸 Thousand Oaks, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

Medical Research Center of Connecticut; 🇺🇸 Hamden, Connecticut, United States

Gastro Florida; 🇺🇸 Clearwater, Florida, United States

Proactive Clinical Research, LLC; 🇺🇸 Fort Lauderdale, Florida, United States

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