NCT06237452From ClinicalTrials.govRecruiting

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

Clostridium Difficile
Clostridium Difficile Infections
Clostridium Difficile Infection Recurrence
Clostridioides Difficile Infection
Clostridioides Difficile Infection Recurrence
CDI
C. Diff Infection
Recurrent Clostridium Difficile Infection

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Vedanta Biosciences, Inc.
Enrolment target: 852
Started: 20 May 2024
Main results due: June 2027
Study sites: 215
Registry updated: 29 September 2026

Can you take part?

Aged 12 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population):

* 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

Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):

* 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

Key Inclusion Criteria (For enrollment in Stage 1 or 2):

* The qualifying episode of CDI must meet all the following criteria:

  1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days
  2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI
  3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory
  4. Diarrhea considered unlikely to have another etiology
* Prior to receiving any study medication, the participant should:

  1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.
  2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days
* 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

Key Exclusion Criteria (For both Stage 1 and Stage 2):

* 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 study is about

In the sponsor’s own words, from the registry.

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).

Study sites(215)

Metro Infectious Disease Consultants
Huntsville, Alabama, United States
Recruiting
Advanced Gastroenterology, P.C.
Chandler, Arizona, United States
Withdrawn
Mayo Clinic Hospital
Phoenix, Arizona, United States
Withdrawn
GI Alliance
Sun City, Arizona, United States
Recruiting
Om Research, LLC
Apple Valley, California, United States
Withdrawn
Science 37 Inc (Remote/Home option)
Culver City, California, United States
Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, United States
Recruiting
VA San Diego Healthcare System
San Diego, California, United States
Recruiting
North America Research Institute
San Dimas, California, United States
Withdrawn
Clinical Trials Management Services
Thousand Oaks, California, United States
Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Recruiting
Connecticut Clinical Research Institute
Bristol, Connecticut, United States
Recruiting
Medical Research Center of Connecticut
Hamden, Connecticut, United States
Recruiting
Hartford Hospital
Hartford, Connecticut, United States
Withdrawn
Gastro Florida
Clearwater, Florida, United States
Recruiting
Proactive Clinical Research, LLC
Fort Lauderdale, Florida, United States
Recruiting
Encore Borland-Groover Clinical Research
Jacksonville, Florida, United States
Recruiting
GI Pros Research
Naples, Florida, United States
Recruiting
Advanced Medical Research Center
Port Orange, Florida, United States
Recruiting
KM International Research Operation LLC
Saint Cloud, Florida, United States
Recruiting
James A. Haley Veterans' Hospital
Tampa, Florida, United States
Recruiting
International Center for Research
Tampa, Florida, United States
Recruiting
Summit Clinical Research, LLC
Athens, Georgia, United States
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Recruiting
Metro Infectious Disease Consultants
Decatur, Georgia, United States
Recruiting
Regional Infectious Diseases and Infusion Center, Inc.
La Grange, Georgia, United States
Withdrawn
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Recruiting
Snake River Research, PLLC
Idaho Falls, Idaho, United States
Recruiting
Metro Infectious Disease Consultants
Burr Ridge, Illinois, United States
Recruiting
NorthShore University Health System - Evanston Hospital
Evanston, Illinois, United States
Withdrawn
GI Alliance
Gurnee, Illinois, United States
Recruiting
Innovative Clinical Research Center, LLC (ICRC)
Island Lake, Illinois, United States
Withdrawn
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Recruiting
Gastroenterology Health Partners
New Albany, Indiana, United States
Recruiting
Deaconess GI Specialty Center
Newburgh, Indiana, United States
Withdrawn
University of Kansas Medical Center
Kansas City, Kansas, United States
Recruiting
IDC Clinical Research, LLC
Wichita, Kansas, United States
Withdrawn
Gastroenterology Health Partners
Louisville, Kentucky, United States
Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, United States
Active, not recruiting
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Recruiting
Tufts Medical Center
Boston, Massachusetts, United States
Withdrawn
Massachusetts General Hospital
Boston, Massachusetts, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Withdrawn
LTC Charles S. Kettles VA Medical Center
Ann Arbor, Michigan, United States
Recruiting
Henry Ford Health
Detroit, Michigan, United States
Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Recruiting
MNGI Digestive Health, PA
Plymouth, Minnesota, United States
Withdrawn
Mayo Clinic
Rochester, Minnesota, United States
Recruiting
Delta Gastroenterology and Endoscopy Center
Southaven, Mississippi, United States
Withdrawn
University of Missouri
Columbia, Missouri, United States
Withdrawn
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
St. Charles Clinical Research
Weldon Spring, Missouri, United States
Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Recruiting
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Recruiting
Northwell Health Division of Infectious Diseases
Manhasset, New York, United States
Recruiting
NYU Grossman School of Medicine
New York, New York, United States
Recruiting
New York Presbyterian Hospital
New York, New York, United States
Recruiting

Showing 60 of 215 sites — filter to narrow it down. 155 of the 215 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06237452. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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