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VE303 for Prevention of Recurrent Clostridioides Difficile Infection | Clinical Trials | Clareo Health

RECRUITINGPHASE3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

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

NCT06237452•Vedanta Biosciences, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. Age ≥ 65 years
•2. Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode
•3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study
•4. History of a prior CDI episode between 6 and 12 months prior to enrollment
•5. Immunosuppression due to an underlying disease or its treatment
•6. Has undergone solid organ or hematopoietic stem cell transplantation
•The qualifying episode of CDI must meet all the following criteria:
+9 more criteria

Exclusion Criteria

•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

Locations (213)

Advanced Gastroenterology, P.C.

Chandler, Arizona, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

GI Alliance

Sun City, Arizona, United States

Om Research, LLC

Apple Valley, California, United States

Science 37 Inc (Remote/Home option)

Culver City, California, United States

Children's Hospital of Los Angeles

Los Angeles, 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

Key Dates

Start Date

May 20, 2024

Primary Completion Date

June 1, 2027

Completion Date

October 1, 2027

Last Updated

March 20, 2026

Enrollment

852

ESTIMATED participants

Conditions

Clostridium DifficileClostridium Difficile InfectionsClostridium Difficile Infection RecurrenceClostridioides Difficile InfectionClostridioides Difficile Infection RecurrenceCDIC. Diff InfectionRecurrent Clostridium Difficile InfectionC.Difficile DiarrheaDiarrhea Infectious

Interventions

VE303

BIOLOGICAL

Placebo

BIOLOGICAL

Contacts

Gary Connor

CONTACT

857-706-1427 Consortium02-ctinquiries@vedantabio.com

Steven Shiff, MD

CONTACT

857-706-1427 Consortium02-ctinquiries@vedantabio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Inclusion Criteria

Exclusion Criteria

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