What is VE303 studying for Clostridioides difficile infection?

VE303 is being studied to see if it can prevent the return of Clostridioides difficile infection after antibiotic treatment. Researchers want to understand its safety and whether it lowers recurrence rates. This trial is sponsored by Vedanta Biosciences, Inc. and focuses on people with recurrent or high-risk primary infections.

Who may be eligible for this Clostridioides difficile infection clinical trial?

Participants must be at least 12 years old with a confirmed CDI episode and either a prior recurrence within 6 months or high risk for recurrence. People with certain chronic diarrhea or intestinal diseases may be excluded. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this Clostridioides difficile infection clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits vary and may not be covered. Participants should plan accordingly for any travel-related costs.

Actively Recruiting

Phase 3

Age: 12Years +

All Genders

ID06237452

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

Led by Vedanta Biosciences, Inc. · Updated on 2026-06-02

852

Participants Needed

215

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating VE303, a live biotherapeutic product made of eight nonpathogenic bacterial strains, for preventing recurrence of Clostridioides difficile infection CDI. This Phase 3, randomized, double-blind, placebo-controlled trial aims to assess the safety and rate of CDI recurrence eight weeks after treatment. The study includes participants with either recurrent CDI or primary CDI at high risk of recurrence, comparing VE303 to a placebo. Participants receive either VE303 or placebo capsules three times daily for 14 days, following 10 to 21 days of standard antibiotic treatment for CDI. VE303 capsules contain the active live bacteria, while placebo capsules contain inactive ingredients and look identical. The study is divided into two stages focusing on recurrent CDI and high-risk primary CDI populations. During the trial, participants are monitored for CDI recurrence over eight weeks, with assessments including stool sample testing and symptom tracking. The study evaluates the effectiveness of VE303 in preventing CDI from returning after initial antibiotic treatment, while monitoring participant safety. Total participation time includes the treatment period plus follow-up to week 8.

CONDITIONS

Brief Title

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Who Can Participate

Age: 12Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 12 years or older (18 years or older in some locations) with a laboratory-confirmed qualifying CDI episode and at least one prior CDI occurrence within the last 6 months (Stage 1)
Age 75 years or older with a laboratory-confirmed qualifying CDI episode (Stage 2)
Or age 12 years or older (18 years or older in some locations) with at least two risk factors: age 65 years or older, kidney dysfunction, recent use of proton pump inhibitors, prior CDI episode 6-12 months ago, immunosuppression, or organ transplantation (Stage 2)
Qualifying CDI episode includes new onset of at least 3 unformed bowel movements per day for 2 consecutive days, symptoms started within 4 weeks before antibiotic therapy, positive stool test for CDI, and diarrhea unlikely from other causes
Completed 10 to 28 days of standard antibiotic therapy for CDI with clinical response (less than 3 loose stools per day for 2 consecutive days)
Able to start study drug on last day of antibiotic treatment or within 2 days after finishing antibiotics
Recovered and clinically stable from severe CDI complications by time of randomization

You will not qualify if you...

Chronic diarrhea unrelated to CDI lasting 4 or more weeks within 3 months before randomization
Known or suspected toxic megacolon or small bowel ileus at randomization
History of celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or recent intestinal ischemia or ischemic colitis
Received bezlotoxumab during antibiotic treatment for qualifying CDI episode
Used antidiarrheal drugs within 3 days before first study drug dose
Expected to receive antibiotics for non-CDI infections from randomization through Week 24
Probiotics prohibited within 2 days before and during study drug dosing (food-based probiotics like yogurt allowed)
Absolute neutrophil count below specified thresholds before randomization

Research Team

Gary Connor

Steven Shiff, MD

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