VE303 for Prevention of Recurrent Clostridioides Difficile Infection
NCT ID: NCT06237452
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
852 participants
INTERVENTIONAL
2024-05-20
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Vedanta Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Advanced Gastroenterology, P.C.
Chandler, Arizona, United States
Mayo Clinic Hospital
Phoenix, 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
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
Innovative Clinical Research Center, LLC (ICRC)
Island Lake, Illinois, United States
Indiana University Health University Hospital
Indianapolis, 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
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
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
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
Vanderbilt University Medical Center
Nashville, Tennessee, 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
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Seattle Infectious Disease Clinic
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, 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
Napoli, 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
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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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At-home study participation for US participants - Science 37
US Participants - Determine if you qualify
Other Identifiers
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VE303-003
Identifier Type: -
Identifier Source: org_study_id
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