VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Vedanta Biosciences, Inc. · NCT06237452
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 852
- US sites recruiting
- 56
- Study start
- May 20, 2024
- Record last updated
- September 29, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: VE303; Placebo
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
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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:
- Age ≥ 65 years
- Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode
- 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
- History of a prior CDI episode between 6 and 12 months prior to enrollment
- Immunosuppression due to an underlying disease or its treatment
- 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:
- New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days
- CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI
- 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
- Diarrhea considered unlikely to have another etiology
- Prior to receiving any study medication, the participant should:
- 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.
- 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
Recruiting US locations
Metro Infectious Disease Consultants
Huntsville, AL 35801
Site contact: Aundrea Bevis · 256-469-7200 · abevis@innovativeventures.com
GI Alliance
Sun City, AZ 85351
Site contact: Samuel Cordivin · 623-972-2116 · scordivin@arizonadigestivehealth.com
Science 37 Inc (Remote/Home option)
Culver City, CA 90230
Site contact: Debra Weinstein, MD · 323-815-7793 · restorative303@science37.com
Children's Hospital of Los Angeles
Los Angeles, CA 90027
Site contact: Victor Yu · 323-361-8481 · vyu@chla.usc.edu
VA San Diego Healthcare System
San Diego, CA 92161
Site contact: David Looney, MD · (858) 552-8585 · David.Looney@va.gov
Clinical Trials Management Services
Thousand Oaks, CA 91360
Site contact: Teresa Tocher · 805-906-7800 · siteservices@clinicaltrialsmanagementservices.com
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, CA 90502
Site contact: Janine La Page · 310-222-4104 · jlapage@lundquist.org
Connecticut Clinical Research Institute
Bristol, CT 06010
Site contact: Cecile Guttermuth · 860-585-3838 · cguttermuth@connecticutgi.org
Medical Research Center of Connecticut
Hamden, CT 06518
Site contact: Candace Cotto · 904-680-0871 · ccotto@gastrocenter.org
Gastro Florida
Clearwater, FL 33756
Site contact: Tara Wasson-Olden · 727-347-0005 · tolden@gastrofl.com
Proactive Clinical Research, LLC
Fort Lauderdale, FL 33308
Site contact: Carolyn Zambrano · 954-938-2843 · czambrano@proactivecr.com
Encore Borland-Groover Clinical Research
Jacksonville, FL 32256
Site contact: Cynthia Buda · 904-621-0390 · cbuda@encoredocs.com
GI Pros Research
Naples, FL 34102
Site contact: Paula Allain · 239-649-1336 · pallainresearch@gmail.com
Advanced Medical Research Center
Port Orange, FL 32127
Site contact: Mohamed Alharami · 386-767-8800 · mhekmat@amrcus.com
KM International Research Operation LLC
Saint Cloud, FL 34769
Site contact: Kadidia Kone-Merchant · 321-805-4774 · kad@kminternationalresearchoperationllc.com
James A. Haley Veterans' Hospital
Tampa, FL 33612
Site contact: John F Toney, MD · 813-972-2000 · john.toney@va.gov
International Center for Research
Tampa, FL 33614
Site contact: Laura Porro · 786-308-1157 · Lporro@ICR-Health.org
Summit Clinical Research, LLC
Athens, GA 30607
Site contact: Jeffrey Williams, MD · jwilliams@summitclinicalstudies.com
Emory University Hospital Midtown
Atlanta, GA 30308
Site contact: Nirja Mehta, MD · 470-839-5804 · nirja.mehta@emory.edu
Metro Infectious Disease Consultants
Decatur, GA 30033
Site contact: Jaol Matos · jmatos@idsatlanta.com
Gastrointestinal Specialists of Georgia
Marietta, GA 30060
Site contact: Octavia Nichols · 678-819-4237 · onichols@gigeorgia.com
Snake River Research, PLLC
Idaho Falls, ID 83404
Site contact: Jennifer Morrison · 208-535-8406 · jmorrison@snakerr.com
Metro Infectious Disease Consultants
Burr Ridge, IL 60527
Site contact: Sarah Arnold · 630-655-8441 · sarnold@innovativeventures.com
GI Alliance
Gurnee, IL 60031
Site contact: Emma Lamblin · 224-441-2217 · Emma.Lamblin@gialliance.com
Indiana University Health University Hospital
Indianapolis, IN 46202
Site contact: Renee Hewitt · 317-278-9294 · iuibd@iupui.edu
Gastroenterology Health Partners
New Albany, IN 47150
Site contact: Brandon Daly · (812) 945-0145 · Brandy.Daly@onegi.com
University of Kansas Medical Center
Kansas City, KS 66160
Site contact: Melissa Willer · 913-945-6770 · mwiller@kumc.edu
Gastroenterology Health Partners
Louisville, KY 40218
Site contact: Brandon Daly · (812) 945-0145 · Brandy.Daly@onegi.com
Ochsner Clinic Foundation
New Orleans, LA 70121
Site contact: Julie Castex · 504-842-7154 · jcastex@ochsner.org
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, MD 20815
Site contact: Gilbert Horst · 301-652-5520 · ghorst@jointopo.com
Massachusetts General Hospital
Boston, MA 02114
Site contact: Elizabeth Hohmann, MD · 617-724-7432 · ehohmann@mgh.harvard.edu
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Grace Hardwick · 617-525-7011 · ghardwick@bwh.harvard.edu
LTC Charles S. Kettles VA Medical Center
Ann Arbor, MI 48105
Site contact: Kimberly Nofz · 734-845-5522 · kimberly.nofz@va.gov
Henry Ford Health
Detroit, MI 48202
Site contact: Anita Shallal, MD · 313-850-7032 · ashalla2@hfhs.org
Corewell Health William Beaumont University Hospital
Royal Oak, MI 48073
Site contact: Maureen Cooney · 248-551-2544 · Maureen.Cooney@corewellhealth.org
University of Minnesota Medical Center
Minneapolis, MN 55455
Site contact: Makenzie Richard · 612-625-8090 · rich1400@umn.edu
Mayo Clinic
Rochester, MN 55905
Site contact: Patricia Kramer · 507-538-1827 · kammer.patricia@mayo.edu
Washington University School of Medicine
St Louis, MO 63110
Site contact: Teresa Arb · 314-747-1217 · arbt@wustl.edu
St. Charles Clinical Research
Weldon Spring, MO 63304
Site contact: Kelly Moushey · k.moushey@stcharlesclinicalresearch.com
Rutgers Robert Wood Johnson Medical School
New Brunswick, NJ 08901
Site contact: Therese Pagulayan · 732-235-6128 · tup1@rwjms.rutgers.edu
South Jersey Infectious Disease
Somers Point, NJ 08244
Site contact: Kelly Freeman · 609-927-6662 · kelly.freeman@sjidtrials.net
Northwell Health Division of Infectious Diseases
Manhasset, NY 11030
Site contact: Jessica Rao · 516-562-3363 · JCabildo@Northwell.edu
NYU Grossman School of Medicine
New York, NY 10016
Site contact: Nathasha Melukkaran · 646-754-3417 · Nathasha.melukkaran@nyulangone.org
New York Presbyterian Hospital
New York, NY 10021
Site contact: Tiffany Min · 646-962-4463 · tim9064@med.cornell.edu
Susquehanna Research Group - Gastroenterology
Harrisburg, PA 17110
Site contact: Jessica Balay · 717-914-7770 · jbalay@gicare.com
Children's Hospital of Philadelphia
Philadelphia, PA 19104
Site contact: Kelly Menna · 215-590-3669 · mennak@chop.edu
Frontier Clinical Research
Uniontown, PA 15401
Site contact: Kim Chapman · 724-596-8036 · kchapman@frontierclinical.com
Medical University of South Carolina
Charleston, SC 29425
Site contact: Alicia Hartley · 843-792-4100 · hartleal@musc.edu
Gastro One Research
Cordova, TN 38018
Site contact: Stephanie Bhula · 901-309-6031 · sbhula@gastro1.com
Vanderbilt University Medical Center
Nashville, TN 37232
Site contact: Emily Cleveland · 615-396-0177 · emily.f.cleveland@vumc.org
GI Alliance
Cedar Park, TX 78613
Site contact: Alexa Payne · 512-341-0900 · Alexa.Payne@GiAlliance.com
North Texas Infectious Disease Consultants, P.A.
Dallas, TX 75246
Site contact: Jessica Caldwell · 214-823-2533 · jessica.caldwell@ntidc.org
GI Alliance
Lubbock, TX 79410
Site contact: Chase Mosley · 806-793-3141 · chase.mosley@gialliance.com
GI Alliance
Richmond, VA 23229
Site contact: Kristy Satkowski · 804-362-0954 · Kristy.Satkowski@gastrova.com
Virginia Mason Medical Center
Seattle, WA 98101
Site contact: Emily Chesterfield · 206-341-1416 · emily.chesterfield@commonspirit.org
Wisconsin Center for Advanced Research
Milwaukee, WI 53207
Site contact: Lisa Cannon · 414-908-6630 · lisac@wigia.com
Study contacts (from the official record)
- Gary Connor · 857-706-1427 · Consortium02-ctinquiries@vedantabio.com
- Steven Shiff, MD · 857-706-1427 · Consortium02-ctinquiries@vedantabio.com