VE303 for Prevention of Recurrent Clostridioides Difficile Infection

PHASE3RecruitingINTERVENTIONAL
Enrollment

852

Participants

Timeline

Start Date

May 20, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

October 31, 2027

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

Trial Locations (197)

9

RECRUITING

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

1070

RECRUITING

Erasme University Hospital - Infectiology Department, Anderlecht

1088

RECRUITING

Semmelweis Egyetem, Budapest

1200

RECRUITING

Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc, Brussels

1407

RECRUITING

Medical Center Excelsior OOD, Base 1, Sofia

2139

RECRUITING

Concord Repatriation General Hospital, Concord

2148

RECRUITING

Westmead Hospital, Westmead

2800

RECRUITING

Komárom-Esztergom Vármegyei Szent Borbála Kórház, Tatabánya

3050

RECRUITING

Melbourne Health, Parkville

3168

RECRUITING

Monash Health, Clayton

3600

RECRUITING

Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD, Lom

4003

RECRUITING

Medicinski centar Hipokrat-N EOOD, Plovdiv

4400

RECRUITING

Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház, Nyíregyháza

5100

RECRUITING

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

5600

RECRUITING

Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza, Békéscsaba

8000

RECRUITING

UMHAT Burgas AD, Burgas

8200

RECRUITING

Aarhus University Hospital, Aarhus

8800

RECRUITING

MHAT Dr.Ivan Seliminski - Sliven Ltd., Sliven

9000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

10016

RECRUITING

NYU Grossman School of Medicine, New York

10021

RECRUITING

New York Presbyterian Hospital, New York

10279

RECRUITING

Manhattan Clinical Research, LLC, New York

10467

ACTIVE_NOT_RECRUITING

Montefiore Medical Center, The Bronx

11030

RECRUITING

Northwell Health Division of Infectious Diseases, Manhasset

12157

RECRUITING

Epimed GmbH, Berlin

13210

RECRUITING

Syracuse VA Medical Center, Syracuse

14004

RECRUITING

Hospital Universitario Reina Sofia, Córdoba

15006

RECRUITING

Complexo Hospitalario Universitario A Coruña, A Coruña

15121

RECRUITING

AO Nazionale SS. Antonio e Biagio e C. Arrigo, Alessandria

15401

RECRUITING

Frontier Clinical Research, Uniontown

17110

RECRUITING

Susquehanna Research Group - Gastroenterology, Harrisburg

18840

RECRUITING

Guthrie Medical Group, PC, Sayre

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

20014

RECRUITING

H. U. Donostia, San Sebastián

20116

RECRUITING

Centro de Investigacion Medica Aguascalientes, Aguascalientes

20157

RECRUITING

Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco, Milan

20230

RECRUITING

Hospital Cardiologica Aguascalientes - Investigacion, Aguascalientes

20815

RECRUITING

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

20900

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori, Monza

21079

RECRUITING

Hôpital du Bocage, Dijon

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

23900

RECRUITING

PO A. Manzoni di Lecco, ASST Lecco, Lecco

26426

RECRUITING

Yonsei University, Wonju Severance Christian Hospital, Wŏnju

27100

RECRUITING

IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia

28007

RECRUITING

Gregorio Marañón University Hospital, Madrid

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28046

RECRUITING

Hospital Universitario La Paz - UCICEC, Madrid

28222

RECRUITING

Hospital Universitario Puerta De Hierro Majadahonda, Majadahonda

29401

RECRUITING

Ralph H. Johnson VA Health Care System, Charleston

RECRUITING

Ralph H. Johnson VA Health Care System, Charleston

29414

RECRUITING

Lowcountry Infectious Diseases, P.A., Charleston

29425

RECRUITING

Medical University of South Carolina, Charleston

30033

RECRUITING

Metro Infectious Disease Consultants, Decatur

30060

RECRUITING

Gastrointestinal Specialists of Georgia, Marietta

30240

RECRUITING

Regional Infectious Diseases and Infusion Center, Inc., La Grange

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

30607

RECRUITING

Summit Clinical Research, LLC, Athens

31029

RECRUITING

Presidio Ospedaliero di Vittorio Veneto, Vittorio Veneto

31096

RECRUITING

Rambam Health Care Campus, Haifa

32127

RECRUITING

Advanced Medical Research Center, Port Orange

32256

RECRUITING

Encore Borland-Groover Clinical Research, Jacksonville

33075

RECRUITING

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

33308

RECRUITING

Proactive Clinical Research, LLC, Fort Lauderdale

33612

RECRUITING

James A. Haley Veterans' Hospital, Tampa

33614

RECRUITING

International Center for Research, Tampa

33756

RECRUITING

Gastro Florida, Clearwater

34102

RECRUITING

GI Pros Research, Naples

34406

RECRUITING

Carmel Medical Center, Haifa

34769

RECRUITING

KM International Research Operation LLC, Saint Cloud

37044

RECRUITING

Chru De Tours, Tours

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

38671

RECRUITING

Delta Gastroenterology and Endoscopy Center, Southaven

41009

RECRUITING

Hospital Universitario Virgen De La Macarena, Seville

41014

RECRUITING

Hospital Universitario Virgen Macarena, Seville

41124

RECRUITING

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

43617

RECRUITING

Toledo Institute of Clinical Research, Toledo

44093

RECRUITING

CHU de Nantes - Hôtel Dieu, Nantes

46202

RECRUITING

Indiana University Health University Hospital, Indianapolis

47630

RECRUITING

Deaconess GI Specialty Center, Newburgh

48073

RECRUITING

Corewell Health William Beaumont University Hospital, Royal Oak

48105

RECRUITING

LTC Charles S. Kettles VA Medical Center, Ann Arbor

48202

RECRUITING

Henry Ford Health, Detroit

50937

RECRUITING

University Hospital Cologne AöR - Klinik I für Innere Medizin, Cologne

55446

RECRUITING

MNGI Digestive Health, PA, Plymouth

55455

RECRUITING

University of Minnesota Medical Center, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

56124

RECRUITING

AOU Pisana - Stabilimento di Cisanello, Pisa

60042

RECRUITING

Innovative Clinical Research Center, LLC (ICRC), Island Lake

60201

RECRUITING

NorthShore University Health System - Evanston Hospital, Evanston

60527

RECRUITING

Metro Infectious Disease Consultants, Burr Ridge

60590

RECRUITING

University Hospital Frankfurt, Frankfurt am Main

63110

RECRUITING

Washington University School of Medicine, St Louis

63304

RECRUITING

St. Charles Clinical Research, Weldon Spring

64239

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

64460

RECRUITING

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

65212

RECRUITING

University of Missouri, Columbia

66160

RECRUITING

University of Kansas Medical Center, Kansas City

67211

RECRUITING

IDC Clinical Research, LLC, Wichita

69004

RECRUITING

Hôpital De La Croix Rousse - Gastroenterology, Lyon

70121

RECRUITING

Ochsner Clinic Foundation, New Orleans

73104

RECRUITING

Oklahoma City Veterans Affairs Healthcare System, Oklahoma City

75014

RECRUITING

Hospital St. Joseph, Les Paris

75018

RECRUITING

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

75246

RECRUITING

North Texas Infectious Disease Consultants, P.A., Dallas

77478

RECRUITING

Simcare Medical Research, LLC, Sugar Land

77494

WITHDRAWN

BioStar Clinical Research, Katy

80131

RECRUITING

Azienda Ospedaliera Universitaria Federico II, Napoli

80756

RECRUITING

KMU Chung-Ho Memorial Hospital, Kaohsiung City

83404

RECRUITING

Snake River Research, PLLC, Idaho Falls

85224

RECRUITING

Advanced Gastroenterology, P.C., Chandler

90230

RECRUITING

Science 37 Inc (Remote/Home option), Culver City

90502

RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

91120

RECRUITING

Hadassah Medical Centre, Jerusalem

91360

RECRUITING

Clinical Trials Management Services, Thousand Oaks

91773

RECRUITING

North America Research Institute, San Dimas

91900

RECRUITING

FAICIC S de RL de C.V. - Gastroenterology, Veracruz

92161

RECRUITING

VA San Diego Healthcare System, San Diego

92307

RECRUITING

Om Research, LLC, Apple Valley

92380

RECRUITING

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

98101

RECRUITING

Seattle Infectious Disease Clinic, Seattle

RECRUITING

Virginia Mason Medical Center, Seattle

200073

RECRUITING

Centrul Medical Renasterea, Craiova

300723

RECRUITING

Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara, Timișoara

333423

RECRUITING

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital, Taoyuan District

400348

RECRUITING

Spitalul Clinic de Boli Infectioase Cluj-Napoca, Cluj-Napoca

404327

RECRUITING

China Medical University Hospital - Infectious, Taichung

700116

RECRUITING

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

3810101

RECRUITING

Hillel Yaffe MC, Clinical Research Unit, Hadera

4941492

RECRUITING

Rabin Medical Center - Beilinson Hospital, Petah Tikva

5265601

RECRUITING

The Chaim Sheba Medical Center, Tel Litwinsky

7030000

RECRUITING

Shamir Medical Center (Assaf Harofeh), Ẕerifin

7830604

RECRUITING

The Barzilai Medical Center, Ashkelon

06518

RECRUITING

Medical Research Center of Connecticut, Hamden

06102

WITHDRAWN

Hartford Hospital, Hartford

02111

RECRUITING

Tufts Medical Center, Boston

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham and Women's Hospital, Boston

08901

RECRUITING

Rutgers Robert Wood Johnson Medical School, New Brunswick

08244

RECRUITING

South Jersey Infectious Disease, Somers Point

30150-221

RECRUITING

CCIH - Consultoria em Controle de Infecção Hospitalar Ltda, Belo Horizonte

80810-040

RECRUITING

Hospital Nossa Senhora das Graças, Curitiba

59025-050

RECRUITING

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

95070-561

RECRUITING

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

90035-903

RECRUITING

Hospital de Clinicas de Porto Alegre - UFRGS, Porto Alegre

01323-903

RECRUITING

Hospital Alemao Oswaldo Cruz, São Paulo

T2N 2T9

RECRUITING

Alberta Health Services (AHS) - Foothills Medical Centre, Calgary

T6G 2X8

RECRUITING

University of Alberta, Edmonton

T4P 1K4

RECRUITING

CaRe Clinic, Red Deer

V5Z 1M9

RECRUITING

Vancouver Coastal Health Research Institute Clinical Research Unit, Vancouver

E1C 4B7

RECRUITING

The Moncton Hospital, Moncton

A1B3V6

RECRUITING

NL Health Services, St. John's

L8N 4A6

RECRUITING

Research St. Josephs Hamilton, Hamilton

N6A 4V2

RECRUITING

St. Joseph's Hospital - London, London

M1P 2T7

RECRUITING

Viable Clinical Research Corporation, Scarborough Village

M5G 1L7

RECRUITING

University Health Network, Toronto

G7H 7Y8

RECRUITING

INTERMED groupe santé, Chicoutimi

G1V 4G2

RECRUITING

Centre Hospitalier de l Universite Laval (CHUL), Québec

625 00

RECRUITING

Fakultni nemocnice Brno, Brno

697 01

WITHDRAWN

Nemocnice Kyjov, p.o., Kyjov

708 52

RECRUITING

Fakultni Nemocnice Ostrava, Ostrava-Poruba

51092 Reims Cedex

RECRUITING

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

0112

RECRUITING

ISR-GEO Med Res Clin Healthycore, Tbilisi

0160

RECRUITING

"LTD Academician Vakhtang Bochorishvili Clinic", Tbilisi

RECRUITING

"LTD Aversi Clinic", Tbilisi

0159

RECRUITING

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

H-6725

RECRUITING

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

A92 VW28

RECRUITING

Our Lady of Lourdes Hospital, Drogheda

00165

RECRUITING

Osp. Pediatrico Bambino Gesù, IRCCS, Roma

00186

RECRUITING

Ospedale Isola Tiberina Gemelli Isola, Roma

2333 ZA

RECRUITING

Leids Universitair Medisch Centrum (LUMC), Leiden

3584 CX

RECRUITING

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

03-580

WITHDRAWN

NZOZ VIVAMED Jadwiga Miecz, Warsaw

40-600

RECRUITING

Gyncentrum sp. z o.o., Katowice

4835-044

RECRUITING

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

3004-591

RECRUITING

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

2805-267

RECRUITING

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

4710-243

RECRUITING

CCAB Centro Clinico Academico Braga Associacao - ULS Braga, Braga

6301-858

RECRUITING

Unidade Local de Saúde da Guarda (ULSG), Guarda

4050-011

RECRUITING

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

4434-502

RECRUITING

Unidade Local De Saude De Gaia/Espinho E.P.E., Vila Nova de Gaia

021105

RECRUITING

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

030303

RECRUITING

Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes, Bucharest

06351

RECRUITING

Samsung Medical Center, Seoul

07441

RECRUITING

Hallym University Kangnam Sacred Heart Hospital, Seoul

08916

RECRUITING

Hospital Universitari Germans Trias i Pujol, Badalona

08907

RECRUITING

Hospital Universitario de Bellvitge, Barcelona

08221

RECRUITING

Hospital Universitario Mutua de Terrassa, Terrassa

03010

RECRUITING

Hospital General Universitario Dr Balmis, Alicante

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

08041

RECRUITING

Hospital de La Santa Creu i Sant Pau, Barcelona

BH7 7DW

WITHDRAWN

The Royal Bournemouth Hospital, Bournemouth

BS10 5NB

RECRUITING

North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre, Bristol

EH4 2XU

RECRUITING

NHS Lothian - Western General Hospital, Edinburgh

NW3 2QG

RECRUITING

Royal Free London NHS Foundation Trust, London

SE1 7EH

RECRUITING

St.Thomas' Hospital, London

S5 7AU

RECRUITING

Northern General Hospital, Sheffield

SA6 6NL

RECRUITING

Morriston Hospital, Swansea

All Listed Sponsors
lead

Vedanta Biosciences, Inc.

INDUSTRY