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VE303 for Preventing Recurrent C. difficile Infection

This study is testing an investigational product called VE303 to see if it can prevent Clostridioides difficile infection (CDI) from coming back. VE303 is a "live biotherapeutic product" (LBP), which means it contains helpful bacteria. You would receive either VE303 or a placebo (an inactive capsule that looks identical to VE303). Researchers want to see how safe VE303 is and how well it prevents CDI recurrence 8 weeks after treatment. You may be able to join if you are at least 12 years old and have had CDI before, or if you are 75 or older and at high risk for CDI recurrence. The study is currently recruiting participants.

Study design
This interventional study plans to enroll 852 participants. It compares VE303 to a placebo, meaning some participants will receive the active product and others will receive an inactive capsule.
What's involved
You would receive a 14-day course of either VE303 or placebo. The study will evaluate your CDI recurrence rate at Week 8.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure CDI recurrence rate at Week 8 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06237452

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Recruiting
PHASE3Ages 12+InterventionalPrevention
Vedanta Biosciences, Inc.
~852 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:VE303Placebo

At a glance

Recruiting sites
155 of 215 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CDI Recurrence Rate at Week 8
Measured over 8 weeks

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

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Clostridium difficile Infection

Where it's being run

215 sites across 112 states
Florida8
California7
Spain7
United Kingdom7
Georgia6
New York6
Texas6
Bulgaria5

Who to contact

Gary Connor
[email protected]
857-706-1427
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months
Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI
OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:
The qualifying episode of CDI must meet all the following criteria:
Prior to receiving any study medication, the participant should:
Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing
Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization

Exclusion

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
Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug
Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)
Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.)
Absolute neutrophil count (ANC) of \< 0.5 ×10\^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \< 1.0 × 10\^9 cells/L

What this trial measures

  • CDI Recurrence Rate at Week 88 weeks

    Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.