Recruiting

Phase 3

VE303VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Sponsor:

Vedanta Biosciences, Inc.

Code:

NCT06237452

Conditions

Clostridium Difficile

Clostridium Difficile Infections

Clostridium Difficile Infection Recurrence

Clostridioides Difficile Infection

Clostridioides Difficile Infection Recurrence

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

VE303

Placebo

Study Details

Brief 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).

Conditions

Clostridium Difficile

Clostridium Difficile Infections

Clostridium Difficile Infection Recurrence

Clostridioides Difficile Infection

Clostridioides Difficile Infection Recurrence

Study ID

NCT06237452

Start date

May 20, 2024

Status verified date

Oct, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

852 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: VE303

Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.

placebo comparator: Placebo

Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.

Interventions

VE303

VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions.

Placebo

Placebo capsules contain microcrystalline cellulose. Placebo capsules are visually identical to and not discernible from VE303 capsules. Placebo capsules will not contain any VE303 drug product.

Primary outcome measure

CDI Recurrence Rate at Week 8 [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Gary Connor

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

Steven Shiff, MD

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

Locations

Metro Infectious Disease Consultants

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Aundrea Bevis

256-469-7200 abevis@innovativeventures.com

GI Alliance

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Samuel Cordivin

623-972-2116 scordivin@arizonadigestivehealth.com

Science 37 Inc (Remote/Home option)

Recruiting

Culver City, California, United States, 90230

Contacts

Debra Weinstein, MD

323-815-7793 restorative303@science37.com

Children's Hospital of Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Victor Yu

323-361-8481 vyu@chla.usc.edu

VA San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

David Looney, MD

(858) 552-8585 David.Looney@va.gov

Clinical Trials Management Services

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Teresa Tocher

805-906-7800 siteservices@clinicaltrialsmanagementservices.com

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Recruiting

Torrance, California, United States, 90502

Contacts

Janine La Page

310-222-4104 jlapage@lundquist.org

Connecticut Clinical Research Institute

Recruiting

Bristol, Connecticut, United States, 06010

Contacts

Cecile Guttermuth

860-585-3838 cguttermuth@connecticutgi.org

Medical Research Center of Connecticut

Recruiting

Hamden, Connecticut, United States, 06518

Contacts

Candace Cotto

904-680-0871 ccotto@gastrocenter.org

Gastro Florida

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Tara Wasson-Olden

727-347-0005 tolden@gastrofl.com

Shannon Brewington

772-336-7682 sbrewington@gastrofl.com

Proactive Clinical Research, LLC

Recruiting

Fort Lauderdale, Florida, United States, 33308

Contacts

Carolyn Zambrano

954-938-2843 czambrano@proactivecr.com

Encore Borland-Groover Clinical Research

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Cynthia Buda

904-621-0390 cbuda@encoredocs.com

GI Pros Research

Recruiting

Naples, Florida, United States, 34102

Contacts

Paula Allain

239-649-1336 pallainresearch@gmail.com

Advanced Medical Research Center

Recruiting

Port Orange, Florida, United States, 32127

Contacts

Mohamed Alharami

386-767-8800 mhekmat@amrcus.com

KM International Research Operation LLC

Recruiting

Saint Cloud, Florida, United States, 34769

Contacts

Kadidia Kone-Merchant

321-805-4774 kad@kminternationalresearchoperationllc.com

James A. Haley Veterans' Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

John F Toney, MD

813-972-2000 john.toney@va.gov

International Center for Research

Recruiting

Tampa, Florida, United States, 33614

Contacts

Laura Porro

786-308-1157 Lporro@ICR-Health.org

Summit Clinical Research, LLC

Recruiting

Athens, Georgia, United States, 30607

Contacts

Jeffrey Williams, MD

jwilliams@summitclinicalstudies.com

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Nirja Mehta, MD

470-839-5804 nirja.mehta@emory.edu

Jennifer Truell

404-778-0014 jennifer.carter.truell@emory.edu

Metro Infectious Disease Consultants

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Jaol Matos

jmatos@idsatlanta.com

Gastrointestinal Specialists of Georgia

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Octavia Nichols

678-819-4237 onichols@gigeorgia.com

Snake River Research, PLLC

Recruiting

Idaho Falls, Idaho, United States, 83404

Contacts

Jennifer Morrison

208-535-8406 jmorrison@snakerr.com

Metro Infectious Disease Consultants

Recruiting

Burr Ridge, Illinois, United States, 60527

Contacts

Sarah Arnold

630-655-8441 sarnold@innovativeventures.com

GI Alliance

Recruiting

Gurnee, Illinois, United States, 60031

Contacts

Emma Lamblin

224-441-2217 Emma.Lamblin@gialliance.com

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Renee Hewitt

317-278-9294 iuibd@iupui.edu

Debbie Drenzyk

317-948-9212 iuibd@iupui.edu

Gastroenterology Health Partners

Recruiting

New Albany, Indiana, United States, 47150

Contacts

Brandon Daly

(812) 945-0145 Brandy.Daly@onegi.com

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Melissa Willer

913-945-6770 mwiller@kumc.edu

KUMC Research Administration

researchadministration@kumc.edu

Gastroenterology Health Partners

Recruiting

Louisville, Kentucky, United States, 40218

Contacts

Brandon Daly

(812) 945-0145 Brandy.Daly@onegi.com

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Julie Castex

504-842-7154 jcastex@ochsner.org

MGG Group Co., Inc., Chevy Chase Clinical Research

Recruiting

Chevy Chase, Maryland, United States, 20815

Contacts

Gilbert Horst

301-652-5520 ghorst@jointopo.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Elizabeth Hohmann, MD

617-724-7432 ehohmann@mgh.harvard.edu

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Grace Hardwick

617-525-7011 ghardwick@bwh.harvard.edu

LTC Charles S. Kettles VA Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Kimberly Nofz

734-845-5522 kimberly.nofz@va.gov

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Anita Shallal, MD

313-850-7032 ashalla2@hfhs.org

Corewell Health William Beaumont University Hospital

Recruiting

Royal Oak, Michigan, United States, 48073

Contacts

Maureen Cooney

248-551-2544 Maureen.Cooney@corewellhealth.org

University of Minnesota Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Makenzie Richard

612-625-8090 rich1400@umn.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Patricia Kramer

507-538-1827 kammer.patricia@mayo.edu

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Teresa Arb

314-747-1217 arbt@wustl.edu

St. Charles Clinical Research

Recruiting

Weldon Spring, Missouri, United States, 63304

Contacts

Kelly Moushey

k.moushey@stcharlesclinicalresearch.com

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Therese Pagulayan

732-235-6128 tup1@rwjms.rutgers.edu

South Jersey Infectious Disease

Recruiting

Somers Point, New Jersey, United States, 08244

Contacts

Kelly Freeman

609-927-6662 kelly.freeman@sjidtrials.net

Northwell Health Division of Infectious Diseases

Recruiting

Manhasset, New York, United States, 11030

Contacts

Jessica Rao

516-562-3363 JCabildo@Northwell.edu

Andrew Diaz

adiaz34@northwell.edu

NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

Nathasha Melukkaran

646-754-3417 Nathasha.melukkaran@nyulangone.org

New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10021

Contacts

Tiffany Min

646-962-4463 tim9064@med.cornell.edu

Susquehanna Research Group - Gastroenterology

Recruiting

Harrisburg, Pennsylvania, United States, 17110

Contacts

Jessica Balay

717-914-7770 jbalay@gicare.com

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kelly Menna

215-590-3669 mennak@chop.edu

Frontier Clinical Research

Recruiting

Uniontown, Pennsylvania, United States, 15401

Contacts

Kim Chapman

724-596-8036 kchapman@frontierclinical.com

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Alicia Hartley

843-792-4100 hartleal@musc.edu

Gastro One Research

Recruiting

Cordova, Tennessee, United States, 38018

Contacts

Stephanie Bhula

901-309-6031 sbhula@gastro1.com

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Emily Cleveland

615-396-0177 emily.f.cleveland@vumc.org

GI Alliance

Recruiting

Cedar Park, Texas, United States, 78613

Contacts

Alexa Payne

512-341-0900 Alexa.Payne@GiAlliance.com

North Texas Infectious Disease Consultants, P.A.

Recruiting

Dallas, Texas, United States, 75246

Contacts

Jessica Caldwell

214-823-2533 jessica.caldwell@ntidc.org

GI Alliance

Recruiting

Lubbock, Texas, United States, 79410

Contacts

Chase Mosley

806-793-3141 chase.mosley@gialliance.com

GI Alliance

Recruiting

Richmond, Virginia, United States, 23229

Contacts

Kristy Satkowski

804-362-0954 Kristy.Satkowski@gastrova.com

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Emily Chesterfield

206-341-1416 emily.chesterfield@commonspirit.org

Wisconsin Center for Advanced Research

Recruiting

Milwaukee, Wisconsin, United States, 53207

Contacts

Lisa Cannon

414-908-6630 lisac@wigia.com

Alberta Health Services (AHS) - Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Thomas Louie, MD

403-944-2038 thomas.louie@albertahealthservices.ca

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2X8

Contacts

Rose Franz

780-248-1342 Rose.Franz@albertahealthservices.ca

CaRe Clinic

Recruiting

Red Deer, Alberta, Canada, T4P 1K4

Contacts

Kayla Tiessen

587-815-0803 kayla@careclinicrd.ca

Vancouver Coastal Health Research Institute Clinical Research Unit

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Ariel Huang

604-875-4111 Ariel.huang@vch.ca

The Moncton Hospital

Recruiting

Moncton, New Brunswick, Canada, E1C 4B7

Contacts

Chantal Houser

506-857-5669 chantal.houser@horizonnb.ca

NL Health Services

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B3V6

Contacts

Marie Josephine Faye

709-777-2953 marie.faye@nlhealthservices.ca

Research St. Josephs Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Adam Weerdenburg

905-522-1155 aweerden@stjosham.on.ca

St. Joseph's Hospital - London

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Mahnaz Kazi

519-646-6100 Mahnaz.Kazi@sjhc.london.on.ca

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 1L7

Contacts

Maria Kulikova

647-469-7457 Maria.kulikova@uhn.ca

INTERMED groupe santé

Recruiting

Chicoutimi, Quebec, Canada, G7H 7Y8

Contacts

Nancy Lavoie

418-602-6620 n.lavoie@intermedgs.ca

Centre Hospitalier de l Universite Laval (CHUL)

Recruiting

Québec, Quebec, Canada, G1V 4G2

Contacts

Isabelle Chabot

418-525-4444 isabelle.chabot@crchudequebec.ulaval.ca

More Information

Sponsor

Vedanta Biosciences, Inc.

Last update posted

Jul 27, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vedanta Biosciences, Inc. on 2026-07-27.