Clostridium DifficilePhase 3RESTORATiVE303NCT06237452
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
A Phase 3 study testing VE303 in people with Clostridium Difficile and Clostridium Difficile Infections, run by Vedanta Biosciences, Inc. at 215 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence
- What is being tested?
- VE303
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 852 participants
- Where
- 215 sitesin 24 countries
- Study dates
- 20 May 2024to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
215 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
215 sites in 24 countries
United States84 sites, 52 recruiting
- Recruiting
LTC Charles S. Kettles VA Medical Center
Ann Arbor, Michigan, 48105
Kimberly Nofz, 734-845-5522, kimberly.nofz@va.gov
- Withdrawn
Om Research, LLC
Apple Valley, California, 92307
- Recruiting
Summit Clinical Research, LLC
Athens, Georgia, 30607
Jeffrey Williams, MD, jwilliams@summitclinicalstudies.com
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Nirja Mehta, MD, 470-839-5804, nirja.mehta@emory.edu
Jennifer Truell, 404-778-0014, jennifer.carter.truell@emory.edu
- Active, not recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Withdrawn
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Elizabeth Hohmann, MD, 617-724-7432, ehohmann@mgh.harvard.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Grace Hardwick, 617-525-7011, ghardwick@bwh.harvard.edu
- Recruiting
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010
Cecile Guttermuth, 860-585-3838, cguttermuth@connecticutgi.org
- Recruiting
Metro Infectious Disease Consultants
Burr Ridge, Illinois, 60527
Sarah Arnold, 630-655-8441, sarnold@innovativeventures.com
- Recruiting
GI Alliance
Cedar Park, Texas, 78613
Alexa Payne, 512-341-0900, Alexa.Payne@GiAlliance.com
- Withdrawn
Advanced Gastroenterology, P.C.
Chandler, Arizona, 85224
- Withdrawn
Ralph H. Johnson VA Health Care System
Charleston, South Carolina, 29401
- Withdrawn
Lowcountry Infectious Diseases, P.A.
Charleston, South Carolina, 29414
- Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Gilbert Horst, 301-652-5520, ghorst@jointopo.com
- Recruiting
Gastro Florida
Clearwater, Florida, 33756
Tara Wasson-Olden, 727-347-0005 ext. 1, tolden@gastrofl.com
Shannon Brewington, 772-336-7682, sbrewington@gastrofl.com
- Withdrawn
University of Missouri
Columbia, Missouri, 65212
- Recruiting
Gastro One Research
Cordova, Tennessee, 38018
Stephanie Bhula, 901-309-6031, sbhula@gastro1.com
- Recruiting
Science 37 Inc (Remote/Home option)
Culver City, California, 90230
Debra Weinstein, MD, 323-815-7793, restorative303@science37.com
- Active, not recruiting
North Texas Infectious Disease Consultants, P.A.
Dallas, Texas, 75246
- Recruiting
Metro Infectious Disease Consultants
Decatur, Georgia, 30033
Jaol Matos, jmatos@idsatlanta.com
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Anita Shallal, MD, 313-850-7032, ashalla2@hfhs.org
- Withdrawn
NorthShore University Health System - Evanston Hospital
Evanston, Illinois, 60201
- Recruiting
Proactive Clinical Research, LLC
Fort Lauderdale, Florida, 33308
Carolyn Zambrano, 954-938-2843, czambrano@proactivecr.com
- Recruiting
GI Alliance
Gurnee, Illinois, 60031
Emma Lamblin, 224-441-2217, Emma.Lamblin@gialliance.com
- Recruiting
Medical Research Center of Connecticut
Hamden, Connecticut, 06518
Candace Cotto, 904-680-0871, ccotto@gastrocenter.org
- Recruiting
Susquehanna Research Group - Gastroenterology
Harrisburg, Pennsylvania, 17110
Jessica Balay, 717-914-7770, jbalay@gicare.com
- Withdrawn
Hartford Hospital
Hartford, Connecticut, 06102
- Withdrawn
University of Houston College of Pharmacy
Houston, Texas, 77204
- Recruiting
Metro Infectious Disease Consultants
Huntsville, Alabama, 35801
Aundrea Bevis, 256-469-7200, abevis@innovativeventures.com
- Recruiting
Snake River Research, PLLC
Idaho Falls, Idaho, 83404
Jennifer Morrison, 208-535-8406, jmorrison@snakerr.com
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Renee Hewitt, 317-278-9294, iuibd@iupui.edu
Debbie Drenzyk, 317-948-9212, iuibd@iupui.edu
- Withdrawn
Innovative Clinical Research Center, LLC (ICRC)
Island Lake, Illinois, 60042
- Recruiting
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
Cynthia Buda, 904-621-0390, cbuda@encoredocs.com
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Melissa Willer, 913-945-6770, mwiller@kumc.edu
KUMC Research Administration, researchadministration@kumc.edu
- Withdrawn
BioStar Clinical Research
Katy, Texas, 77494
- Withdrawn
Regional Infectious Diseases and Infusion Center, Inc.
La Grange, Georgia, 30240
- Recruiting
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Victor Yu, 323-361-8481, vyu@chla.usc.edu
- Recruiting
Gastroenterology Health Partners
Louisville, Kentucky, 40218
Brandon Daly, (812) 945-0145, Brandy.Daly@onegi.com
- Recruiting
GI Alliance
Lubbock, Texas, 79410
Chase Mosley, 806-793-3141, chase.mosley@gialliance.com
- Recruiting
Northwell Health Division of Infectious Diseases
Manhasset, New York, 11030
Jessica Rao, 516-562-3363, JCabildo@Northwell.edu
Andrew Diaz, adiaz34@northwell.edu
- Recruiting
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Octavia Nichols, 678-819-4237, onichols@gigeorgia.com
- Recruiting
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207
Lisa Cannon, 414-908-6630, lisac@wigia.com
- Recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Makenzie Richard, 612-625-8090, rich1400@umn.edu
- Recruiting
GI Pros Research
Naples, Florida, 34102
Paula Allain, 239-649-1336, pallainresearch@gmail.com
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Emily Cleveland, 615-396-0177, emily.f.cleveland@vumc.org
- Recruiting
Gastroenterology Health Partners
New Albany, Indiana, 47150
Brandon Daly, (812) 945-0145, Brandy.Daly@onegi.com
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Therese Pagulayan, 732-235-6128, tup1@rwjms.rutgers.edu
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Julie Castex, 504-842-7154, jcastex@ochsner.org
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
Nathasha Melukkaran, 646-754-3417, Nathasha.melukkaran@nyulangone.org
- Active, not recruiting
New York Presbyterian Hospital
New York, New York, 10021
- Withdrawn
Manhattan Clinical Research, LLC
New York, New York, 10279
- Withdrawn
Deaconess GI Specialty Center
Newburgh, Indiana, 47630
- Withdrawn
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
- Withdrawn
Oklahoma City Veterans Affairs Healthcare System
Oklahoma City, Oklahoma, 73104
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Kelly Menna, 215-590-3669, mennak@chop.edu
- Withdrawn
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Withdrawn
MNGI Digestive Health, PA
Plymouth, Minnesota, 55446
- Recruiting
Advanced Medical Research Center
Port Orange, Florida, 32127
Mohamed Alharami, 386-767-8800, mhekmat@amrcus.com
- Recruiting
GI Alliance
Richmond, Virginia, 23229
Kristy Satkowski, 804-362-0954, Kristy.Satkowski@gastrova.com
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Patricia Kramer, 507-538-1827, kammer.patricia@mayo.edu
- Recruiting
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Maureen Cooney, 248-551-2544, Maureen.Cooney@corewellhealth.org
- Recruiting
KM International Research Operation LLC
Saint Cloud, Florida, 34769
Kadidia Kone-Merchant, 321-805-4774, kad@kminternationalresearchoperationllc.com
- Recruiting
VA San Diego Healthcare System
San Diego, California, 92161
David Looney, MD, (858) 552-8585 ext. 2585, David.Looney@va.gov
- Withdrawn
North America Research Institute
San Dimas, California, 91773
- Withdrawn
Guthrie Medical Group, PC
Sayre, Pennsylvania, 18840
- Withdrawn
Seattle Infectious Disease Clinic
Seattle, Washington, 98101
- Active, not recruiting
Virginia Mason Medical Center
Seattle, Washington, 98101
- Recruiting
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
Kelly Freeman, 609-927-6662 ext. 5, kelly.freeman@sjidtrials.net
- Withdrawn
Delta Gastroenterology and Endoscopy Center
Southaven, Mississippi, 38671
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Teresa Arb, 314-747-1217, arbt@wustl.edu
- Withdrawn
Simcare Medical Research, LLC
Sugar Land, Texas, 77478
- Recruiting
GI Alliance
Sun City, Arizona, 85351
Samuel Cordivin, 623-972-2116 ext. 1271, scordivin@arizonadigestivehealth.com
- Terminated
Syracuse VA Medical Center
Syracuse, New York, 13210
- Recruiting
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
John F Toney, MD, 813-972-2000 ext. 6697, john.toney@va.gov
- Recruiting
International Center for Research
Tampa, Florida, 33614
Laura Porro, 786-308-1157, Lporro@ICR-Health.org
- Terminated
Montefiore Medical Center
The Bronx, New York, 10467
- Recruiting
Clinical Trials Management Services
Thousand Oaks, California, 91360
Teresa Tocher, 805-906-7800, siteservices@clinicaltrialsmanagementservices.com
- Withdrawn
Toledo Institute of Clinical Research
Toledo, Ohio, 43617
- Recruiting
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Janine La Page, 310-222-4104, jlapage@lundquist.org
- Recruiting
Frontier Clinical Research
Uniontown, Pennsylvania, 15401
Kim Chapman, 724-596-8036, kchapman@frontierclinical.com
- Recruiting
St. Charles Clinical Research
Weldon Spring, Missouri, 63304
Kelly Moushey, k.moushey@stcharlesclinicalresearch.com
- Withdrawn
IDC Clinical Research, LLC
Wichita, Kansas, 67211
Spain15 sites, 14 recruiting
- Recruiting
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
Brais Castelo, +34607507910, brais.castelo@gmail.com
- Recruiting
Hospital General Universitario Dr Balmis
Alicante, 03010
Livia Giner Oncina, +34 965 91 35 75, livginer@gmail.com
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Elena Abad, +34 93 497 83 49, eabad@scienhub.org
- Recruiting
Hospital Universitario de Bellvitge
Barcelona, Barcelona, 08907
Judit Orobitg Bernandes, 34 93 260 75 00, orobitg@bellvitgehospital.cat
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
Montserrat Solà Vidal Solà Vidal, +34932275400, msola@recerca.clinic.cat
- Recruiting
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Iris Artesero Sosa, +34625916595, IArtesero@santpau.cat
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
Patricia Cosano Perez, +34633339548, patricia.cosano@imibic.org
- Recruiting
Gregorio Marañón University Hospital
Madrid, Madrid, 28007
Sara Rodriguez, +34915865492, sara.rodriguezinvestigacion@hotmail.com
- Recruiting
Hospital Universitario La Paz - UCICEC
Madrid, Madrid, 28046
Ana Maria Ortega, +34912071876, ana.ucicec@gmail.com
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Celia Cano Sanz, +34913369071, celiacanosz.ec@gmail.com
- Recruiting
Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda, Madrid, 28222
Paloma Rodríguez Araque, +34911916481, farmacologia_clinica@idiphim.org
- Recruiting
H. U. Donostia
San Sebastián, Guipúzcoa, 20014
Claudia Nevado Pavón, +34 943003535, claudia.nevadopavon@bio-gipuzkoa.eus
- Recruiting
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41014
María del Rocio Herrero del Río, +34955015871, rocio.herrero.delrio@gmail.com
- Recruiting
Hospital Universitario Virgen De La Macarena
Seville, 41009
Virginia Palomo Jimenez Palomo Jimenez, +34955926553, virgi2015@hotmail.com
- Active, not recruiting
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, 08221
Canada12 sites, 11 recruiting
- Recruiting
Alberta Health Services (AHS) - Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Thomas Louie, MD, 403-944-2038, thomas.louie@albertahealthservices.ca
- Recruiting
INTERMED groupe santé
Chicoutimi, Quebec, G7H 7Y8
Nancy Lavoie, 418-602-6620, n.lavoie@intermedgs.ca
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2X8
Rose Franz, 780-248-1342, Rose.Franz@albertahealthservices.ca
- Recruiting
Research St. Josephs Hamilton
Hamilton, Ontario, L8N 4A6
Adam Weerdenburg, 905-522-1155 ext. 32553, aweerden@stjosham.on.ca
- Recruiting
St. Joseph's Hospital - London
London, Ontario, N6A 4V2
Mahnaz Kazi, 519-646-6100, Mahnaz.Kazi@sjhc.london.on.ca
- Recruiting
The Moncton Hospital
Moncton, New Brunswick, E1C 4B7
Chantal Houser, 506-857-5669, chantal.houser@horizonnb.ca
- Recruiting
Centre Hospitalier de l Universite Laval (CHUL)
Québec, Quebec, G1V 4G2
Isabelle Chabot, 418-525-4444 ext. 47778, isabelle.chabot@crchudequebec.ulaval.ca
- Recruiting
CaRe Clinic
Red Deer, Alberta, T4P 1K4
Kayla Tiessen, 587-815-0803, kayla@careclinicrd.ca
- Withdrawn
Viable Clinical Research Corporation
Scarborough Village, Ontario, M1P 2T7
- Recruiting
NL Health Services
St. John's, Newfoundland and Labrador, A1B3V6
Marie Josephine Faye, 709-777-2953, marie.faye@nlhealthservices.ca
- Recruiting
University Health Network
Toronto, Ontario, M5G 1L7
Maria Kulikova, 647-469-7457, Maria.kulikova@uhn.ca
- Recruiting
Vancouver Coastal Health Research Institute Clinical Research Unit
Vancouver, British Columbia, V5Z 1M9
Ariel Huang, 604-875-4111 ext. 69697, Ariel.huang@vch.ca
Italy11 sites, 7 recruiting
- Recruiting
AO Nazionale SS. Antonio e Biagio e C. Arrigo
Alessandria, Alessandria, 15121
Gabriel Corbo, +39 0131 206893, gabriel.corbo@aou.al.it
- Recruiting
PO A. Manzoni di Lecco, ASST Lecco
Lecco, Lombardy, 23900
Silvia Pontiggia, +390341253678, s.pontiggia@asst-lecco.it
- Active, not recruiting
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, Milano, 20157
- Recruiting
Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali
Modena, Reggio Emilia, 41124
Barbara Beghetto, +39 0594223673, nb.protocolli@unimo.it
- Active, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza, 20900
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, Napoli, 80131
Maria Scirocco, +393714534488, mmichelascirocco@hotmail.com
- Recruiting
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, Pavia, 27100
Mattia Demitri, +39 0382 502523, m.demitri@smatteo.pv.it
- Recruiting
AOU Pisana - Stabilimento di Cisanello
Pisa, 56124
Marco Falcone, MD, +39 050 996735, marco.falcone@unipi.it
- Active, not recruiting
Osp. Pediatrico Bambino Gesù, IRCCS
Roma, Roma, 00165
- Recruiting
Ospedale Isola Tiberina Gemelli Isola
Roma, 00186
Caterina Fanali, +390630155923, caterina.fanali@fbf-isola.it
- Active, not recruiting
Presidio Ospedaliero di Vittorio Veneto
Vittorio Veneto, Veneto, 31029
France9 sites, 6 recruiting
- Active, not recruiting
CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses
Bordeaux Cedex, Hauts-de-France, 33075
- Recruiting
Hôpital du Bocage
Dijon, Franche-Comté, 21079
Carole Charles, +33380295240, carole.charles@chu-dijon.fr
- Active, not recruiting
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare
Garches, Hauts-de-Seine, 92380
- Active, not recruiting
Hospital St. Joseph
Les Paris, Auvergne-Rhône-Alpes, 75014
- Recruiting
Hôpital De La Croix Rousse - Gastroenterology
Lyon, Rhone, 69004
Emma Sandoz, +33426732862, emma.sandoz@chu-lyon.fr
- Recruiting
CHU de Nantes - Hôtel Dieu
Nantes, Loire-Atlantique, 44093
Jérémie Orain, 33 02 53 48 24 25, jeremie.orain@chu-nantes.fr
- Recruiting
Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre
Paris, Grand Est, 51092 Reims Cedex
Giovanni Farace, +33 (0)326784152, gfarace@chu-reims.fr
- Recruiting
Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales
Paris, Paris, 75018
Lynda Chalal, 33 1 40 25 87 79, lynda.chalal@aphp.fr
- Recruiting
Chru De Tours
Tours, 37044
Mohamed Dribek, +33 2 47 47 86 22, m.dribek@chu-tours.fr
Israel9 sites, 5 recruiting
- Recruiting
The Barzilai Medical Center
Ashkelon, Southern District, 7830604
Pnina Nir, +972-8-6745765, pninan@bmc.gov.il
- Active, not recruiting
Hillel Yaffe MC, Clinical Research Unit
Hadera, Haifa North, 3810101
- Active, not recruiting
Carmel Medical Center
Haifa, Haifa District, 34406
- Recruiting
Rambam Health Care Campus
Haifa, 31096
Ilan Davidov, +972546559224, il_davidov@rambam.health.gov.il
Anastasia Weis, +972544518702, A_WEIS@rambam.health.gov.il
- Withdrawn
Hadassah Medical Centre
Jerusalem, Jerusalem, 91120
- Active, not recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Central District, 4941492
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Central District, 64239
Nurit Platner, +972524266763, nuritp@tlvmc.gov.il
- Recruiting
The Chaim Sheba Medical Center
Tel HaShomer, 5265601
Shlomit Romano, +97235303500, Shlomit.Romano@sheba.health.gov.il
- Recruiting
Shamir Medical Center (Assaf Harofeh)
Tsrifin, Central District, 7030000
Hodaya Hanya, 08-9542268, hodayah@shamir.gov.il
United Kingdom8 sites, 6 recruiting
- Withdrawn
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW
- Recruiting
North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre
Bristol, BS10 5NB
Kirstie Bradburn, +4401174148102, Kirstie.Bradburn@nbt.nhs.uk
- Recruiting
NHS Lothian - Western General Hospital
Edinburgh, EH4 2XU
Amy Shepherd, +4401315372840, Amy.shepherd@nhs.scot
- Withdrawn
Royal Devon University Healthcare NHS Trust
Exeter, Devon, EX2 5DW
- Recruiting
Royal Free London NHS Foundation Trust
London, NW3 2QG
Audrey Abdul, +442074726446, Audrey.abdul@nhs.net
- Recruiting
St.Thomas' Hospital
London, SE1 7EH
Alieza Rara, +4402071887188 ext. 53339, Alieza.Rara@gstt.nhs.uk
- Recruiting
Northern General Hospital
Sheffield, S5 7AU
Priya Lata, +4401142715779, priya.lata@nhs.net
- Recruiting
Morriston Hospital
Swansea, SA6 6NL
Elaine Brinkworth, +4401792986806, Elaine.Brinkworth@wales.nhs.uk
Brazil7 sites, 4 recruiting
- Active, not recruiting
CCIH - Consultoria em Controle de Infecção Hospitalar Ltda
Belo Horizonte, Minas Gerais, 30150-221
- Active, not recruiting
Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, 95070-561
- Recruiting
Hospital Nossa Senhora das Graças
Curitiba, Paraná, 80810-040
Otavio Henrique Tomczak Paulichei, +55 41999150238, otavio.cmsf@gmail.com
- Recruiting
CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica
Natal, Rio Grande do Norte, 59025-050
Sibele Araujo, 55 84 99172-0060, sibelearaujo@cpclinrn.com.br
- Recruiting
Hospital de Clinicas de Porto Alegre - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903
Taiane Vieira, (51) 3359-6256, tavieira@hcpa.edu.br
- Active, not recruiting
Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
Porto Alegre, Rio Grande do Sul, 90880-480
- Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01323-903
Daniela Maia, 551135491542, daniela.maia@haoc.com.br
Portugal7 sites
- Withdrawn
Unidade Local De Saude De Almada-Seixal E.P.E.
Almada, Lisbon District, 2805-267
- Withdrawn
CCAB Centro Clinico Academico Braga Associacao - ULS Braga
Braga, 4710-243
- Withdrawn
Unidade Local De Saude De Coimbra E.P.E.
Coimbra, Coimbra District, 3004-591
- Withdrawn
Unidade Local de Saúde da Guarda (ULSG)
Guarda, 6301-858
- Withdrawn
Unidade Local De Saude Do Alto Ave E.P.E.
Guimarães, Braga District, 4835-044
- Withdrawn
Unidade Local De Saude De Santo Antonio E.P.E.
Porto, 4050-011
- Withdrawn
Unidade Local De Saude De Gaia/Espinho E.P.E.
Vila Nova de Gaia, 4434-502
Bulgaria6 sites
- Withdrawn
UMHAT Burgas AD
Burgas, 8000
- Active, not recruiting
Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Gorna Oryahovitsa, 5100
- Withdrawn
Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD
Lom, 3600
- Withdrawn
Medicinski centar Hipokrat-N EOOD
Plovdiv, 4003
- Withdrawn
MHAT Dr.Ivan Seliminski - Sliven Ltd.
Sliven, 8800
- Withdrawn
Medical Center Excelsior OOD, Base 1
Sofia, Sofia-Grad, 1407
Romania6 sites, 3 recruiting
- Recruiting
Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V
Bucharest, Bucharest, 021105
Daniela Manolache, +40723120150, dani_voicu2001@yahoo.com
- Recruiting
Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes
Bucharest, Bucharest, 030303
Nicoleta Baloseanu, +40763709113, nicoleta.baloseanu@gmail.com
- Active, not recruiting
Spitalul Clinic de Boli Infectioase Cluj-Napoca
Cluj-Napoca, Cluj, 400348
- Withdrawn
Centrul Medical Renasterea
Craiova, Dolj, 200073
- Recruiting
Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi - Infectious diseases I
Iași, Iaşi, 700116
Andrei Vata, MD, +40740160580, andreiandrei@yahoo.com
- Withdrawn
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, Timiș County, 300723
Hungary5 sites
- Withdrawn
Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
Békéscsaba, Bekes County, 5600
- Active, not recruiting
Semmelweis Egyetem
Budapest, 1088
- Withdrawn
Szabolcs-Szatmár-Bereg Vármegyei Oktatókórház Nyíregyházi Jósa András Tagkórház
Nyíregyháza, 4400
- Withdrawn
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
Szeged, Csongrád megye, H-6725
- Active, not recruiting
Komárom-Esztergom Vármegyei Szent Borbála Kórház
Tatabánya, Komárom-Esztergom, 2800
Mexico5 sites, 4 recruiting
- Recruiting
Centro de Investigacion Medica Aguascalientes
Aguascalientes, Aguascalientes, 20116
Daniela Portillo, +5539392977, daniela.portillo@osmomexico.com
- Recruiting
Hospital Cardiologica Aguascalientes - Investigacion
Aguascalientes, Aguascalientes, 20230
Luz Delgado Munoz, 524499154000 ext. 315, majkamaria-6@hotmail.com
- Recruiting
JM Research S.C - Pediatrics
Cuernavaca, Morelos, 62290
Rita Márquez Hernández, 52 777 263 32 00, rita@jmresearch.org
- Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Infectious Diseases
Monterrey, Nuevo León, 64460
Ximena Tovar Sosa, 528671484520, ximenatovarso00@gmail.com
- Active, not recruiting
FAICIC S de RL de C.V. - Gastroenterology
Veracruz, Veracruz, 91900
Australia4 sites
- Withdrawn
Monash Health
Clayton, Victoria, 3168
- Withdrawn
Concord Repatriation General Hospital
Concord, New South Wales, 2139
- Withdrawn
Melbourne Health
Parkville, Victoria, 3050
- Withdrawn
Westmead Hospital
Westmead, New South Wales, 2148
Georgia4 sites, 4 recruiting
- Recruiting
ISR-GEO Med Res Clin Healthycore
Tbilisi, K'alak'i T'bilisi, 0112
Manana Anchabadze, 995599777633, anchabadze.m@gmail.com
- Recruiting
LTD "Academician Vakhtang Bochorishvili Clinic"
Tbilisi, K'alak'i T'bilisi, 0160
Sofio Iluridze, 995574856336, Sofio.iluridze@yahoo.com
- Recruiting
LTD "Aversi Clinic"
Tbilisi, K'alak'i T'bilisi, 0160
Maka Katsia, +995 593343266, mkatsia@yahoo.com
- Recruiting
LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
Tbilisi, 0159
Tinatin Kavtaradze, +995599147799, Tinatinkavtaradze11@gmail.com
South Korea4 sites, 3 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, 06351
Ji Eun Kim, 82234103409, happyjinny0706@gmail.com
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, 06591
Yun Jeong, 82 2 2258 2084, yjchoi1689@gmail.com
- Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul Teugbyeolsi, 07441
Bokyung Yun, +10-6728-7172, ybk0618@naver.com
- Active, not recruiting
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Belgium3 sites, 3 recruiting
- Recruiting
Erasme University Hospital - Infectiology Department
Anderlecht, 1070
Odette Mukangenzi, +32025558070, odette.mukangenzi@hubruxelles.be
- Recruiting
Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc
Brussels, 1200
Celine D'Aoust, +323227642190, celine.daoust@saintluc.uclouvain.be
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Els Caluwe, +32093325414, els.caluwe@uzgent.be
Czechia3 sites
- Withdrawn
Fakultni nemocnice Brno
Brno, Brno-město, 625 00
- Withdrawn
Nemocnice Kyjov, p.o.
Kyjov, 697 01
- Withdrawn
Fakultni Nemocnice Ostrava
Ostrava-Poruba, 708 52
Germany3 sites, 3 recruiting
- Recruiting
Epimed GmbH
Berlin, State of Berlin, 12157
Juliane Grube, +49 30 26558370, grube@epimed.org
- Recruiting
University Hospital Cologne AöR - Klinik I für Innere Medizin
Cologne, North Rhine-Westphalia, 50937
Tatjana Lammertz, +4922147897340, tatjana.lammertz@uk-koeln.de
- Recruiting
University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590
Ester Mostazo-Mendoza, +49 69 86540, ester.mostazomendoza@unimedizin-ffm.de
Guido Neumann, +49 69 630185236, Guido.Neumann@unimedizin-ffm.de
Taiwan3 sites, 3 recruiting
- Recruiting
KMU Chung-Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 80756
Yan-Zhen Hsu, +886 963383335, hannah.hsu530@gmail.com
- Recruiting
China Medical University Hospital - Infectious
Taichung, Taichung, 404327
Ya Chun Tang, +886 975297510, yachun620@gmail.com
- Recruiting
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
Taoyuan, Taoyuan, 333423
Wen-Leng Chou, 88633281200 ext. 8848, a5896067@yahoo.com.tw
Ireland2 sites
- Withdrawn
Our Lady of Lourdes Hospital
Drogheda, Louth, A92 VW28
- Withdrawn
Royal College of Surgeons in Ireland - Beaumont Hospital - Education and Research Centre
Dublin, Dublin, 9
Netherlands2 sites, 2 recruiting
- Recruiting
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland, 2333 ZA
Jessica Vlot, +31715261424, j.a.vlot@lumc.nl
Joffrey van Prehn, +310715263931, j.vanprehn@lumc.nl
- Recruiting
Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
Utrecht, 3584 CX
Iris Koevoets, +31887567979, i.a.i.koevoets@umcutrecht.nl
Poland2 sites
- Withdrawn
Gyncentrum sp. z o.o.
Katowice, Silesian Voivodeship, 40-600
- Withdrawn
NZOZ VIVAMED Jadwiga Miecz
Warsaw, Masovian Voivodeship, 03-580
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Toto Nairn, +4551504815, catrmark@rm.dk
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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, CDI
- Being tested
- VE303, Placebo
- Medical subject headings
- Clostridium Infections, Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VE303Biological
VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions.
PlaceboBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| VE303 | Experimental | 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. Receives: Biological: VE303 |
| Placebo | Placebo comparator | 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. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDI Recurrence Rate at Week 8
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start20 May 2024
- Primary completionJun 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedanta Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237452
- Sponsor's protocol ID
- VE303-003
- Other IDs
- 75A50120C00177
- Acronym
- RESTORATiVE303
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT06237452
- Acronym / sponsor ID
- RESTORATiVE303 / VE303-003
- Conditions
- Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence, Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence, CDI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- Vedanta Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VE303 | Experimental | Biological: VE303Subjects 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 | Placebo comparator | Biological: PlaceboSubjects 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- The qualifying episode of CDI must meet all the following criteria:
- Prior to receiving any study medication, the participant should:
- 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 (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VE303VE303 is a live biotherapeutic product (LBP) consisting of 8 clonally derived, nonpathogenic, nontoxigenic, commensal bacteria strains manufactured under Good Manufacturing Practices (GMP) conditions. | Biological | VE303 |
| PlaceboPlacebo 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. | Biological | Placebo |
Primary outcome
CDI Recurrence Rate at Week 8
Time frame: 8 weeks
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- At-home study participation for US participants - Science 37Link provided by the sponsor.
- US Participants - Determine if you qualifyLink provided by the sponsor.
Related trials for Clostridium Difficile
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
215 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VE303 in people with Clostridium Difficile and Clostridium Difficile Infections, run by Vedanta Biosciences, Inc. at 215 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 215 sites in United States, Spain, Canada, Italy, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul McGovern, MD (857-706-1427, Consortium02-ctinquiries@vedantabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDI Recurrence Rate at Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.