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RECRUITING
NCT06237452
PHASE3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Sponsor: 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).

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

852

Start Date

2024-05-20

Completion Date

2027-10

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

Locations (214)

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

Connecticut Clinical Research Institute

Bristol, Connecticut, United States

Medical Research Center of Connecticut

Hamden, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Gastro Florida

Clearwater, Florida, United States

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, United States

Encore Borland-Groover Clinical Research

Jacksonville, Florida, United States

GI Pros Research

Naples, Florida, United States

Advanced Medical Research Center

Port Orange, Florida, United States

KM International Research Operation LLC

Saint Cloud, Florida, United States

James A. Haley Veterans' Hospital

Tampa, Florida, United States

International Center for Research

Tampa, Florida, United States

Summit Clinical Research, LLC

Athens, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Metro Infectious Disease Consultants

Decatur, Georgia, United States

Regional Infectious Diseases and Infusion Center, Inc.

La Grange, Georgia, United States

Gastrointestinal Specialists of Georgia

Marietta, Georgia, United States

Snake River Research, PLLC

Idaho Falls, Idaho, United States

Metro Infectious Disease Consultants

Burr Ridge, Illinois, United States

NorthShore University Health System - Evanston Hospital

Evanston, Illinois, United States

GI Alliance

Gurnee, Illinois, United States

Innovative Clinical Research Center, LLC (ICRC)

Island Lake, Illinois, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

Gastroenterology Health Partners

New Albany, Indiana, United States

Deaconess GI Specialty Center

Newburgh, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

IDC Clinical Research, LLC

Wichita, Kansas, United States

Gastroenterology Health Partners

Louisville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

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

Chevy Chase, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

LTC Charles S. Kettles VA Medical Center

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

MNGI Digestive Health, PA

Plymouth, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Delta Gastroenterology and Endoscopy Center

Southaven, Mississippi, United States

University of Missouri

Columbia, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

St. Charles Clinical Research

Weldon Spring, Missouri, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

Northwell Health Division of Infectious Diseases

Manhasset, New York, United States

NYU Grossman School of Medicine

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

Manhattan Clinical Research, LLC

New York, New York, United States

Syracuse VA Medical Center

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Oklahoma City Veterans Affairs Healthcare System

Oklahoma City, Oklahoma, United States

Susquehanna Research Group - Gastroenterology

Harrisburg, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Guthrie Medical Group, PC

Sayre, Pennsylvania, United States

Frontier Clinical Research

Uniontown, Pennsylvania, United States

Ralph H. Johnson VA Health Care System

Charleston, South Carolina, United States

Lowcountry Infectious Diseases, P.A.

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Gastro One Research

Cordova, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

GI Alliance

Cedar Park, Texas, United States

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas, United States

University of Houston College of Pharmacy

Houston, Texas, United States

BioStar Clinical Research

Katy, Texas, United States

GI Alliance

Lubbock, Texas, United States

Simcare Medical Research, LLC

Sugar Land, Texas, United States

GI Alliance

Richmond, Virginia, United States

Seattle Infectious Disease Clinic

Seattle, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

Melbourne Health

Parkville, Victoria, Australia

Erasme University Hospital - Infectiology Department

Anderlecht, Belgium

Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

CCIH - Consultoria em Controle de Infecção Hospitalar Ltda

Belo Horizonte, Minas Gerais, Brazil

Hospital Nossa Senhora das Graças

Curitiba, Paraná, Brazil

CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica

Natal, Rio Grande do Norte, Brazil

Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Hospital de Clinicas de Porto Alegre - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Medical Center Excelsior OOD, Base 1

Sofia, Sofia-Grad, Bulgaria

UMHAT Burgas AD

Burgas, Bulgaria

Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD

Gorna Oryahovitsa, Bulgaria

Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD

Lom, Bulgaria

Medicinski centar Hipokrat-N EOOD

Plovdiv, Bulgaria

MHAT Dr.Ivan Seliminski - Sliven Ltd.

Sliven, Bulgaria

Alberta Health Services (AHS) - Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

CaRe Clinic

Red Deer, Alberta, Canada

Vancouver Coastal Health Research Institute Clinical Research Unit

Vancouver, British Columbia, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

NL Health Services

St. John's, Newfoundland and Labrador, Canada

Research St. Josephs Hamilton

Hamilton, Ontario, Canada

St. Joseph's Hospital - London

London, Ontario, Canada

Viable Clinical Research Corporation

Scarborough Village, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

INTERMED groupe santé

Chicoutimi, Quebec, Canada

Centre Hospitalier de l Universite Laval (CHUL)

Québec, Quebec, Canada

Fakultni nemocnice Brno

Brno, Brno-město, Czechia

Nemocnice Kyjov, p.o.

Kyjov, Czechia

Fakultni Nemocnice Ostrava

Ostrava-Poruba, Czechia

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Hospital St. Joseph

Les Paris, Auvergne-Rhône-Alpes, France

Hôpital du Bocage

Dijon, Franche-Comté, France

Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre

Paris, Grand Est, France

CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses

Bordeaux Cedex, Hauts-de-France, France

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare

Garches, Hauts-de-Seine, France

CHU de Nantes - Hôtel Dieu

Nantes, Loire-Atlantique, France

Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales

Paris, Paris, France

Hôpital De La Croix Rousse - Gastroenterology

Lyon, Rhone, France

Chru De Tours

Tours, France

ISR-GEO Med Res Clin Healthycore

Tbilisi, K'alak'i T'bilisi, Georgia

LTD "Academician Vakhtang Bochorishvili Clinic"

Tbilisi, K'alak'i T'bilisi, Georgia

LTD "Aversi Clinic"

Tbilisi, K'alak'i T'bilisi, Georgia

LTD "Emergency Cardiology Center named by Acad.G.Chapidze"

Tbilisi, Georgia

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

University Hospital Cologne AöR - Klinik I für Innere Medizin

Cologne, North Rhine-Westphalia, Germany

Epimed GmbH

Berlin, State of Berlin, Germany

Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Békéscsaba, Bekes County, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika

Szeged, Csongrád megye, Hungary

Komárom-Esztergom Vármegyei Szent Borbála Kórház

Tatabánya, Komárom-Esztergom, Hungary

Semmelweis Egyetem

Budapest, Hungary

Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház

Nyíregyháza, Hungary

Royal College of Surgeons in Ireland - Beaumont Hospital - Education and Research Centre

Dublin, Dublin, Ireland

Our Lady of Lourdes Hospital

Drogheda, Louth, Ireland

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Central District, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Central District, Israel

Shamir Medical Center (Assaf Harofeh)

Ẕerifin, Central District, Israel

Carmel Medical Center

Haifa, Haifa District, Israel

Hillel Yaffe MC, Clinical Research Unit

Hadera, Haifa North, Israel

Hadassah Medical Centre

Jerusalem, Jerusalem, Israel

The Barzilai Medical Center

Ashkelon, Southern District, Israel

Rambam Health Care Campus

Haifa, Israel

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

AO Nazionale SS. Antonio e Biagio e C. Arrigo

Alessandria, Alessandria, Italy

PO A. Manzoni di Lecco, ASST Lecco

Lecco, Lombardy, Italy

Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco

Milan, Milano, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Monza E Brianza, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Napoli, Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavia

Pavia, Pavia, Italy

Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali

Modena, Reggio Emilia, Italy

Osp. Pediatrico Bambino Gesù, IRCCS

Roma, Roma, Italy

Presidio Ospedaliero di Vittorio Veneto

Vittorio Veneto, Veneto, Italy

AOU Pisana - Stabilimento di Cisanello

Pisa, Italy

Ospedale Isola Tiberina Gemelli Isola

Roma, Italy

Centro de Investigacion Medica Aguascalientes

Aguascalientes, Aguascalientes, Mexico

Hospital Cardiologica Aguascalientes - Investigacion

Aguascalientes, Aguascalientes, Mexico

JM Research S.C - Pediatrics

Cuernavaca, Morelos, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Infectious Diseases

Monterrey, Nuevo León, Mexico

FAICIC S de RL de C.V. - Gastroenterology

Veracruz, Veracruz, Mexico

Leids Universitair Medisch Centrum (LUMC)

Leiden, South Holland, Netherlands

Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care

Utrecht, Netherlands

NZOZ VIVAMED Jadwiga Miecz

Warsaw, Masovian Voivodeship, Poland

Gyncentrum sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Unidade Local De Saude Do Alto Ave E.P.E.

Guimarães, Braga District, Portugal

Unidade Local De Saude De Coimbra E.P.E.

Coimbra, Coimbra District, Portugal

Unidade Local De Saude De Almada-Seixal E.P.E.

Almada, Lisbon District, Portugal

CCAB Centro Clinico Academico Braga Associacao - ULS Braga

Braga, Portugal

Unidade Local de Saúde da Guarda (ULSG)

Guarda, Portugal

Unidade Local De Saude De Santo Antonio E.P.E.

Porto, Portugal

Unidade Local De Saude De Gaia/Espinho E.P.E.

Vila Nova de Gaia, Portugal

Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V

Bucharest, București, Romania

Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes

Bucharest, București, Romania

Spitalul Clinic de Boli Infectioase Cluj-Napoca

Cluj-Napoca, Cluj, Romania

Centrul Medical Renasterea

Craiova, Dolj, Romania

Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi - Infectious diseases I

Iași, Iaşi, Romania

Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

Timișoara, Timiș County, Romania

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Bellvitge

Barcelona, Barcelona, Spain

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, Spain

H. U. Donostia

San Sebastián, Guipúzcoa, Spain

Gregorio Marañón University Hospital

Madrid, Madrid, Spain

Hospital Universitario La Paz - UCICEC

Madrid, Madrid, Spain

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital General Universitario Dr Balmis

Alicante, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital de La Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Virgen De La Macarena

Seville, Spain

KMU Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, Taiwan

China Medical University Hospital - Infectious

Taichung, Taichung, Taiwan

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, Taiwan

Royal Devon University Healthcare NHS Trust

Exeter, Devon, United Kingdom

The Royal Bournemouth Hospital

Bournemouth, United Kingdom

North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre

Bristol, United Kingdom

NHS Lothian - Western General Hospital

Edinburgh, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

St.Thomas' Hospital

London, United Kingdom

Northern General Hospital

Sheffield, United Kingdom

Morriston Hospital

Swansea, United Kingdom