Recruiting

RESTORATiVE303VE303 for Recurrent Clostridioides Difficile Infection Prevention

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Study Aim

This Phase 3 study aims to evaluate whether VE303 can prevent the recurrence of Clostridioides difficile infection in adults by observing the recurrence rate at week 8.

What is being tested

VE303

+ Placebo

Biological
Who is being recruted

Bacterial Infections and Mycoses+7

+ Bacterial Infections

+ Clostridium Infections

Over 12 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 3
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorVedanta Biosciences, Inc.
Study ContactGary ConnorMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 20, 2024

Actual date on which the first participant was enrolled.

This study is focused on preventing the recurrence of Clostridioides difficile infection (CDI), a condition that can cause severe diarrhea and other intestinal issues. It targets individuals who have already experienced CDI and are at risk of having it again. The study aims to see if a new treatment, VE303, can reduce the chances of the infection returning compared to a placebo. This is important as recurrent CDI can be difficult to manage and can lead to significant health problems if not effectively controlled. Participants in the study will be randomly assigned to receive either a 14-day course of VE303 or a placebo, which is a substance with no therapeutic effect. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results. The main focus is to monitor the safety of the treatment and how often CDI returns by the end of week 8. This will help determine if VE303 is a safe and effective option for preventing CDI from coming back.

Official TitleA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
NCT06237452
Principal SponsorVedanta Biosciences, Inc.
Study ContactGary ConnorMore contacts
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

852 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsClostridium InfectionsDigestive System DiseasesDysenteryGastroenteritisGastrointestinal DiseasesInfectionsIntestinal DiseasesGram-Positive Bacterial Infections

Criteria

8 exclusion criteria prevent from participating
History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI
Known or suspected toxic megacolon or small bowel ileus at the time of randomization
History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis
Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 213 locations

Recruiting

Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V

Bucharest, RomaniaOpen Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V in Google Maps
Recruiting

Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes

Bucharest, Romania
Recruiting

Spitalul Clinic de Boli Infectioase Cluj-Napoca

Cluj-Napoca, Romania
Recruiting

GI Alliance

Sun City, United States
Recruiting
213 Study Centers