VE303 for Prevention of Recurrent Clostridioides Difficile Infection (RESTORATiVE303)
May 13, 2026 updated by: Vedanta Biosciences, Inc.
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
852
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Steven Shiff, MD
- Phone Number: 857-706-1427
- Email: Consortium02-ctinquiries@vedantabio.com
Study Contact Backup
- Name: Gary Connor
- Phone Number: 857-706-1427
- Email: Consortium02-ctinquiries@vedantabio.com
Study Locations
-
-
New South Wales
-
Concord, New South Wales, Australia, 2139
- Withdrawn
- Concord Repatriation General Hospital
-
Westmead, New South Wales, Australia, 2148
- Withdrawn
- Westmead Hospital
-
-
Victoria
-
Clayton, Victoria, Australia, 3168
- Withdrawn
- Monash Health
-
Parkville, Victoria, Australia, 3050
- Withdrawn
- Melbourne Health
-
-
-
-
-
Anderlecht, Belgium, 1070
- Recruiting
- Erasme University Hospital - Infectiology Department
-
Contact:
- Odette Mukangenzi
- Phone Number: +32025558070
- Email: odette.mukangenzi@hubruxelles.be
-
Brussels, Belgium, 1200
- Recruiting
- Universite Catholique De Louvain and Cliniques Universitaires Saint-Luc
-
Contact:
- Celine D'Aoust
- Phone Number: +323227642190
- Email: celine.daoust@saintluc.uclouvain.be
-
Ghent, Belgium, 9000
- Recruiting
- Universitair Ziekenhuis Gent
-
Contact:
- Els Caluwe
- Phone Number: +32093325414
- Email: els.caluwe@uzgent.be
-
-
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil, 30150-221
- Recruiting
- CCIH - Consultoria em Controle de Infecção Hospitalar Ltda
-
Contact:
- Daniela Mendes
- Phone Number: 55 31 3879 0085
- Email: danielamendes@freirepesquisa.com.br
-
-
Paraná
-
Curitiba, Paraná, Brazil, 80810-040
- Recruiting
- Hospital Nossa Senhora das Graças
-
Contact:
- Otavio Henrique Tomczak Paulichei
- Phone Number: +55 41999150238
- Email: otavio.cmsf@gmail.com
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brazil, 59025-050
- Recruiting
- CPCLIN - Centro de Estudos e Pesquisas em Molestias Infecciosas - Pesquisa Clínica
-
Contact:
- Sibele Araujo
- Phone Number: 55 84 99172-0060
- Email: sibelearaujo@cpclinrn.com.br
-
-
Rio Grande do Sul
-
Caxias do Sul, Rio Grande do Sul, Brazil, 95070-561
- Recruiting
- Fundacao Universidade de Caxias do Sul - Hospital Geral de Caxias do Sul
-
Contact:
- Ramone Bertussi
- Phone Number: 555432187200
- Email: rabertus@ucs.br
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre - UFRGS
-
Contact:
- Taiane Vieira
- Phone Number: (51) 3359-6256
- Email: tavieira@hcpa.edu.br
-
Porto Alegre, Rio Grande do Sul, Brazil, 90880-480
- Recruiting
- Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
-
Contact:
- Gabriela Crestani
- Phone Number: +55 51 3252-3930
- Email: gabriela.crestani@coracentro.com.br
-
-
São Paulo
-
São Paulo, São Paulo, Brazil, 01323-903
- Recruiting
- Hospital Alemao Oswaldo Cruz
-
Contact:
- Daniela Maia
- Phone Number: 551135491542
- Email: daniela.maia@haoc.com.br
-
-
-
-
-
Burgas, Bulgaria, 8000
- Withdrawn
- UMHAT Burgas AD
-
Gorna Oryahovitsa, Bulgaria, 5100
- Recruiting
- Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
-
Contact:
- Alexander Gospodinov
- Phone Number: +359887806101
- Email: gospodinov@mcmedicaplus.com
-
Lom, Bulgaria, 3600
- Withdrawn
- Multiprofile Hospital for Active Treatment Sveti Nikolay Chuditvorets EOOD
-
Plovdiv, Bulgaria, 4003
- Withdrawn
- Medicinski centar Hipokrat-N EOOD
-
Sliven, Bulgaria, 8800
- Withdrawn
- MHAT Dr.Ivan Seliminski - Sliven Ltd.
-
-
Sofia-Grad
-
Sofia, Sofia-Grad, Bulgaria, 1407
- Withdrawn
- Medical Center Excelsior OOD, Base 1
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 2T9
- Recruiting
- Alberta Health Services (AHS) - Foothills Medical Centre
-
Contact:
- Thomas Louie, MD
- Phone Number: 403-944-2038
- Email: thomas.louie@albertahealthservices.ca
-
Edmonton, Alberta, Canada, T6G 2X8
- Recruiting
- University of Alberta
-
Contact:
- Rose Franz
- Phone Number: 780-248-1342
- Email: Rose.Franz@albertahealthservices.ca
-
Red Deer, Alberta, Canada, T4P 1K4
- Recruiting
- CaRe Clinic
-
Contact:
- Kayla Tiessen
- Phone Number: 587-815-0803
- Email: kayla@careclinicrd.ca
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver Coastal Health Research Institute Clinical Research Unit
-
Contact:
- Ariel Huang
- Phone Number: 69697 604-875-4111
- Email: Ariel.huang@vch.ca
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1C 4B7
- Recruiting
- The Moncton Hospital
-
Contact:
- Chantal Houser
- Phone Number: 506-857-5669
- Email: chantal.houser@horizonnb.ca
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada, A1B3V6
- Recruiting
- NL Health Services
-
Contact:
- Marie Josephine Faye
- Phone Number: 709-777-2953
- Email: marie.faye@nlhealthservices.ca
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- Recruiting
- Research St. Josephs Hamilton
-
Contact:
- Adam Weerdenburg
- Phone Number: 32553 905-522-1155
- Email: aweerden@stjosham.on.ca
-
London, Ontario, Canada, N6A 4V2
- Recruiting
- St. Joseph's Hospital - London
-
Contact:
- Mahnaz Kazi
- Phone Number: 519-646-6100
- Email: Mahnaz.Kazi@sjhc.london.on.ca
-
Scarborough Village, Ontario, Canada, M1P 2T7
- Withdrawn
- Viable Clinical Research Corporation
-
Toronto, Ontario, Canada, M5G 1L7
- Recruiting
- University Health Network
-
Contact:
- Maria Kulikova
- Phone Number: 647-469-7457
- Email: Maria.kulikova@uhn.ca
-
-
Quebec
-
Chicoutimi, Quebec, Canada, G7H 7Y8
- Recruiting
- INTERMED Groupe Sante
-
Contact:
- Nancy Lavoie
- Phone Number: 418-602-6620
- Email: n.lavoie@intermedgs.ca
-
Québec, Quebec, Canada, G1V 4G2
- Recruiting
- Centre Hospitalier de l Universite Laval (CHUL)
-
Contact:
- Isabelle Chabot
- Phone Number: 47778 418-525-4444
- Email: isabelle.chabot@crchudequebec.ulaval.ca
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-
-
-
-
Kyjov, Czechia, 697 01
- Withdrawn
- Nemocnice Kyjov, p.o.
-
Ostrava-Poruba, Czechia, 708 52
- Withdrawn
- Fakultni Nemocnice Ostrava
-
-
Brno-město
-
Brno, Brno-město, Czechia, 625 00
- Withdrawn
- Fakultni nemocnice Brno
-
-
-
-
Central Jutland
-
Aarhus, Central Jutland, Denmark, 8200
- Recruiting
- Aarhus University Hospital
-
Contact:
- Toto Nairn
- Phone Number: +4551504815
- Email: catrmark@rm.dk
-
-
-
-
-
Tours, France, 37044
- Recruiting
- CHRU de Tours
-
Contact:
- Mohamed Dribek
- Phone Number: +33 2 47 47 86 22
- Email: m.dribek@chu-tours.fr
-
-
Auvergne-Rhône-Alpes
-
Les Paris, Auvergne-Rhône-Alpes, France, 75014
- Recruiting
- Hospital St. Joseph
-
Contact:
- Sabrina Bousta
- Phone Number: +33 1 44 12 62 07
- Email: sbousta@ghpsj.fr
-
-
Franche-Comté
-
Dijon, Franche-Comté, France, 21079
- Recruiting
- Hôpital du Bocage
-
Contact:
- Carole Charles
- Phone Number: +33380295240
- Email: carole.charles@chu-dijon.fr
-
-
Grand Est
-
Paris, Grand Est, France, 51092 Reims Cedex
- Recruiting
- Centre Hospitalier Universitaire (CHU) de Reims - Hopital Robert Debre
-
Contact:
- Giovanni Farace
- Phone Number: +33 (0)326784152
- Email: gfarace@chu-reims.fr
-
-
Hauts-de-France
-
Bordeaux Cedex, Hauts-de-France, France, 33075
- Recruiting
- CHU Bordeaux - Hopital Saint Andre Service de medecine interne et maladies infectieuses
-
Contact:
- Jean Delaune
- Phone Number: 330557822433
- Email: jean.delaune@chu-bordeaux.fr
-
-
Hauts-de-Seine
-
Garches, Hauts-de-Seine, France, 92380
- Recruiting
- Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Paris Ile-de-France Ouest - Raymond-Poincare
-
Contact:
- Clara Duran
- Phone Number: +33 1 49 09 56 55
- Email: clara.duran@aphp.fr
-
-
Loire-Atlantique
-
Nantes, Loire-Atlantique, France, 44093
- Recruiting
- CHU de Nantes - Hôtel Dieu
-
Contact:
- Jérémie Orain
- Phone Number: 33 02 53 48 24 25
- Email: jeremie.orain@chu-nantes.fr
-
-
Paris
-
Paris, Paris, France, 75018
- Recruiting
- Assistance Publique Hôpitaux de Paris Hôpital Bichat- Claude Bernard - Département des maladies infectieuses et tropicales
-
Contact:
- Lynda Chalal
- Phone Number: 33 1 40 25 87 79
- Email: lynda.chalal@aphp.fr
-
-
Rhone
-
Lyon, Rhone, France, 69004
- Recruiting
- Hôpital De La Croix Rousse - Gastroenterology
-
Contact:
- Emma Sandoz
- Phone Number: +33426732862
- Email: emma.sandoz@chu-lyon.fr
-
-
-
-
-
Tbilisi, Georgia, 0159
- Recruiting
- LTD "Emergency Cardiology Center named by Acad.G.Chapidze"
-
Contact:
- Tinatin Kavtaradze
- Phone Number: +995599147799
- Email: Tinatinkavtaradze11@gmail.com
-
-
K'alak'i T'bilisi
-
Tbilisi, K'alak'i T'bilisi, Georgia, 0112
- Recruiting
- ISR-GEO Med Res Clin Healthycore
-
Contact:
- Manana Anchabadze
- Phone Number: 995599777633
- Email: anchabadze.m@gmail.com
-
Tbilisi, K'alak'i T'bilisi, Georgia, 0160
- Recruiting
- LTD "Academician Vakhtang Bochorishvili Clinic"
-
Contact:
- Sofio Iluridze
- Phone Number: 995574856336
- Email: Sofio.iluridze@yahoo.com
-
Tbilisi, K'alak'i T'bilisi, Georgia, 0160
- Recruiting
- LTD "Aversi Clinic"
-
Contact:
- Maka Katsia
- Phone Number: +995 593343266
- Email: mkatsia@yahoo.com
-
-
-
-
Hesse
-
Frankfurt am Main, Hesse, Germany, 60590
- Recruiting
- University Hospital Frankfurt
-
Contact:
- Guido Neumann
- Phone Number: +49 69 630185236
- Email: Guido.Neumann@unimedizin-ffm.de
-
Contact:
- Ester Mostazo-Mendoza
- Phone Number: +49 69 86540
- Email: ester.mostazomendoza@unimedizin-ffm.de
-
-
North Rhine-Westphalia
-
Cologne, North Rhine-Westphalia, Germany, 50937
- Recruiting
- University Hospital Cologne AöR - Klinik I für Innere Medizin
-
Contact:
- Tatjana Lammertz
- Phone Number: +4922147897340
- Email: tatjana.lammertz@uk-koeln.de
-
-
State of Berlin
-
Berlin, State of Berlin, Germany, 12157
- Recruiting
- Epimed GmbH
-
Contact:
- Juliane Grube
- Phone Number: +49 30 26558370
- Email: grube@epimed.org
-
-
-
-
-
Budapest, Hungary, 1088
- Recruiting
- Semmelweis Egyetem
-
Contact:
- Kinga Kover
- Phone Number: +36206632783
- Email: kover.kinga@semmelweis.hu
-
Nyíregyháza, Hungary, 4400
- Withdrawn
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
-
-
Bekes County
-
Békéscsaba, Bekes County, Hungary, 5600
- Withdrawn
- Bekes Varmegyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza
-
-
Csongrád megye
-
Szeged, Csongrád megye, Hungary, H-6725
- Withdrawn
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
-
-
Komárom-Esztergom
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Tatabánya, Komárom-Esztergom, Hungary, 2800
- Recruiting
- Komarom-Esztergom Varmegyei Szent Borbala Korhaz
-
Contact:
- Adrienn Heisz
- Phone Number: +36 70886-9431
- Email: heisz.adrienn@tatabanyakorhaz.hu
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-
-
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Dublin
-
Dublin, Dublin, Ireland, 9
- Withdrawn
- Royal College of Surgeons in Ireland - Beaumont Hospital - Education and Research Centre
-
-
Louth
-
Drogheda, Louth, Ireland, A92 VW28
- Withdrawn
- Our Lady of Lourdes Hospital
-
-
-
-
-
Haifa, Israel, 31096
- Recruiting
- Rambam Health Care Campus
-
Contact:
- Ilan Davidov
- Phone Number: +972546559224
- Email: il_davidov@rambam.health.gov.il
-
Contact:
- Anastasia Weis
- Phone Number: +972544518702
- Email: A_WEIS@rambam.health.gov.il
-
Tel Litwinsky, Israel, 5265601
- Recruiting
- The Chaim Sheba Medical Center
-
Contact:
- Shlomit Romano
- Phone Number: +97235303500
- Email: Shlomit.Romano@sheba.health.gov.il
-
-
Central District
-
Petah Tikva, Central District, Israel, 4941492
- Recruiting
- Rabin Medical Center - Beilinson Hospital
-
Contact:
- Maayan Huber-Karl
- Phone Number: 972-52-3325417
- Email: maayanhub@clalit.org.il
-
Contact:
- Vered Daitch
- Phone Number: 972-52-3643570
- Email: VeredZa@clalit.org.il
-
Tel Aviv, Central District, Israel, 64239
- Recruiting
- Tel Aviv Sourasky Medical Center
-
Contact:
- Nurit Platner
- Phone Number: +972524266763
- Email: nuritp@tlvmc.gov.il
-
Ẕerifin, Central District, Israel, 7030000
- Recruiting
- Shamir Medical Center (Assaf Harofeh)
-
Contact:
- Hodaya Hanya
- Phone Number: 08-9542268
- Email: hodayah@shamir.gov.il
-
-
Haifa District
-
Haifa, Haifa District, Israel, 34406
- Recruiting
- Carmel Medical Center
-
Contact:
- Moran Rad
- Phone Number: +97254998822
- Email: moranra@clalit.org.il
-
-
Haifa North
-
Hadera, Haifa North, Israel, 3810101
- Recruiting
- Hillel Yaffe MC, Clinical Research Unit
-
Contact:
- Lucy Merhasin
- Phone Number: 972544512396
- Email: lucym@hymc.gov.il
-
Contact:
- Jenny Elber
- Phone Number: +97247744929
- Email: jennye@hymc.gov.il
-
-
Jerusalem
-
Jerusalem, Jerusalem, Israel, 91120
- Recruiting
- Hadassah Medical Centre
-
Contact:
- Jacob Strahilevitz, MD
- Phone Number: +97226776543
- Email: jacobst@hadassah.org.il
-
-
Southern District
-
Ashkelon, Southern District, Israel, 7830604
- Recruiting
- The Barzilai Medical Center
-
Contact:
- Pnina Nir
- Phone Number: +972-8-6745765
- Email: pninan@bmc.gov.il
-
-
-
-
-
Pisa, Italy, 56124
- Recruiting
- AOU Pisana - Stabilimento di Cisanello
-
Contact:
- Marco Falcone, MD
- Phone Number: +39 050 996735
- Email: marco.falcone@unipi.it
-
Roma, Italy, 00186
- Recruiting
- Ospedale Isola Tiberina Gemelli Isola
-
Contact:
- Caterina Fanali
- Phone Number: +390630155923
- Email: caterina.fanali@fbf-isola.it
-
-
Alessandria
-
Alessandria, Alessandria, Italy, 15121
- Recruiting
- AO Nazionale SS. Antonio e Biagio e C. Arrigo
-
Contact:
- Gabriel Corbo
- Phone Number: +39 0131 206893
- Email: gabriel.corbo@aou.al.it
-
-
Lombardy
-
Lecco, Lombardy, Italy, 23900
- Recruiting
- PO A. Manzoni di Lecco, ASST Lecco
-
Contact:
- Silvia Pontiggia
- Phone Number: +390341253678
- Email: s.pontiggia@asst-lecco.it
-
-
Milano
-
Milan, Milano, Italy, 20157
- Recruiting
- Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
-
Contact:
- Olimpia Padula
- Phone Number: +39 02 39042582
- Email: padula.olimpia@asst-fbf-sacco.it
-
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Monza E Brianza
-
Monza, Monza E Brianza, Italy, 20900
- Recruiting
- Fondazione IRCCS San Gerardo dei Tintori
-
Contact:
- Anna Spolti
- Phone Number: +390392339600
- Email: spolti.anna89@gmail.com
-
-
Napoli
-
Naples, Napoli, Italy, 80131
- Recruiting
- Azienda Ospedaliera Universitaria Federico II
-
Contact:
- Maria Scirocco
- Phone Number: +393714534488
- Email: mmichelascirocco@hotmail.com
-
-
Pavia
-
Pavia, Pavia, Italy, 27100
- Recruiting
- IRCCS Policlinico San Matteo, Università degli studi di Pavia
-
Contact:
- Mattia Demitri
- Phone Number: +39 0382 502523
- Email: m.demitri@smatteo.pv.it
-
-
Reggio Emilia
-
Modena, Reggio Emilia, Italy, 41124
- Recruiting
- Azienda Ospedaliero-Universitaria di Modena, Policlinico di Modena - Malattie Infettive E Tropicali
-
Contact:
- Barbara Beghetto
- Phone Number: +39 0594223673
- Email: nb.protocolli@unimo.it
-
-
Roma
-
Roma, Roma, Italy, 00165
- Recruiting
- Osp. Pediatrico Bambino Gesù, IRCCS
-
Contact:
- Giorgia Copponi
- Phone Number: +39 0668592188
- Email: giorgia.copponi@opbg.net
-
-
Veneto
-
Vittorio Veneto, Veneto, Italy, 31029
- Recruiting
- Presidio Ospedaliero di Vittorio Veneto
-
Contact:
- Adriano Mazzer
- Phone Number: +39 0438665337
- Email: amazzer@email.it
-
-
-
-
Aguascalientes
-
Aguascalientes, Aguascalientes, Mexico, 20116
- Recruiting
- Centro de Investigacion Medica Aguascalientes
-
Contact:
- Daniela Portillo
- Phone Number: +5539392977
- Email: daniela.portillo@osmomexico.com
-
Aguascalientes, Aguascalientes, Mexico, 20230
- Recruiting
- Hospital Cardiologica Aguascalientes - Investigacion
-
Contact:
- Luz Delgado Munoz
- Phone Number: 315 524499154000
- Email: majkamaria-6@hotmail.com
-
-
Morelos
-
Cuernavaca, Morelos, Mexico, 62290
- Recruiting
- JM Research S.C - Pediatrics
-
Contact:
- Rita Márquez Hernández
- Phone Number: 52 777 263 32 00
- Email: rita@jmresearch.org
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Recruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Infectious Diseases
-
Contact:
- Ximena Tovar Sosa
- Phone Number: 528671484520
- Email: ximenatovarso00@gmail.com
-
-
Veracruz
-
Veracruz, Veracruz, Mexico, 91900
- Recruiting
- FAICIC S de RL de C.V. - Gastroenterology
-
Contact:
- Astrid Hernandez Gongora
- Phone Number: 2292139780
- Email: astrid.hernandez@faicic.com.mx
-
-
-
-
-
Utrecht, Netherlands, 3584 CX
- Recruiting
- Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care
-
Contact:
- Iris Koevoets
- Phone Number: +31887567979
- Email: i.a.i.koevoets@umcutrecht.nl
-
-
South Holland
-
Leiden, South Holland, Netherlands, 2333 ZA
- Recruiting
- Leids Universitair Medisch Centrum (LUMC)
-
Contact:
- Jessica Vlot
- Phone Number: +31715261424
- Email: j.a.vlot@lumc.nl
-
Contact:
- Joffrey van Prehn
- Phone Number: +310715263931
- Email: j.vanprehn@lumc.nl
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-
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Poland, 03-580
- Withdrawn
- NZOZ VIVAMED Jadwiga Miecz
-
-
Silesian Voivodeship
-
Katowice, Silesian Voivodeship, Poland, 40-600
- Withdrawn
- Gyncentrum Sp. z o.o.
-
-
-
-
-
Braga, Portugal, 4710-243
- Withdrawn
- CCAB Centro Clinico Academico Braga Associacao - ULS Braga
-
Guarda, Portugal, 6301-858
- Withdrawn
- Unidade Local de Saúde da Guarda (ULSG)
-
Porto, Portugal, 4050-011
- Withdrawn
- Unidade Local De Saude De Santo Antonio E.P.E.
-
Vila Nova de Gaia, Portugal, 4434-502
- Withdrawn
- Unidade Local De Saude De Gaia/Espinho E.P.E.
-
-
Braga District
-
Guimarães, Braga District, Portugal, 4835-044
- Withdrawn
- Unidade Local De Saude Do Alto Ave E.P.E.
-
-
Coimbra District
-
Coimbra, Coimbra District, Portugal, 3004-591
- Withdrawn
- Unidade Local De Saude De Coimbra E.P.E.
-
-
Lisbon District
-
Almada, Lisbon District, Portugal, 2805-267
- Withdrawn
- Unidade Local de Saúde de Almada-Seixal E.P.E.
-
-
-
-
Bucharest
-
Bucharest, Bucharest, Romania, 021105
- Recruiting
- Institutul de Boli Infecțioase Prof Dr Matei Bals - Infectious diseases V
-
Contact:
- Daniela Manolache
- Phone Number: +40723120150
- Email: dani_voicu2001@yahoo.com
-
Bucharest, Bucharest, Romania, 030303
- Recruiting
- Spitalul Clinic de Boli Infectioase si Tropicale Dr Victor Babes
-
Contact:
- Nicoleta Baloseanu
- Phone Number: +40763709113
- Email: nicoleta.baloseanu@gmail.com
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400348
- Recruiting
- Spitalul Clinic de Boli Infectioase Cluj-Napoca
-
Contact:
- Astrid Binder
- Phone Number: +40745571470
- Email: astrid_binder2003@yahoo.com
-
-
Dolj
-
Craiova, Dolj, Romania, 200073
- Withdrawn
- Centrul Medical Renasterea
-
-
Iaşi
-
Iași, Iaşi, Romania, 700116
- Recruiting
- Spitalul Clinic de Boli Infectioase Sfanta Parascheva Iasi - Infectious diseases I
-
Contact:
- Andrei Vata, MD
- Phone Number: +40740160580
- Email: andreiandrei@yahoo.com
-
-
Timiș County
-
Timișoara, Timiș County, Romania, 300723
- Withdrawn
- Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara
-
-
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, South Korea, 26426
- Recruiting
- Yonsei University, Wonju Severance Christian Hospital
-
Contact:
- Myung Sook
- Phone Number: 82-31-741-1209
- Email: hmsook119@hanmail.net
-
-
Seoul Teugbyeolsi
-
Seoul, Seoul Teugbyeolsi, South Korea, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Ji Eun Kim
- Phone Number: 82234103409
- Email: happyjinny0706@gmail.com
-
Seoul, Seoul Teugbyeolsi, South Korea, 07441
- Recruiting
- Hallym University Kangnam Sacred Heart Hospital
-
Contact:
- Bokyung Yun
- Phone Number: +10-6728-7172
- Email: ybk0618@naver.com
-
Seoul, Seoul Teugbyeolsi, South Korea, 06591
- Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Contact:
- Yun Jeong
- Phone Number: 82 2 2258 2084
- Email: yjchoi1689@gmail.com
-
-
-
-
-
A Coruña, Spain, 15006
- Recruiting
- Complexo Hospitalario Universitario A Coruña
-
Contact:
- Brais Castelo
- Phone Number: +34607507910
- Email: brais.castelo@gmail.com
-
Alicante, Spain, 03010
- Recruiting
- Hospital General Universitario Dr Balmis
-
Contact:
- Livia Giner Oncina
- Phone Number: +34 965 91 35 75
- Email: livginer@gmail.com
-
Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic de Barcelona
-
Contact:
- Montserrat Solà Vidal Solà Vidal
- Phone Number: +34932275400
- Email: msola@recerca.clinic.cat
-
Barcelona, Spain, 08041
- Recruiting
- Hospital de la Santa Creu i Sant Pau
-
Contact:
- Iris Artesero Sosa
- Phone Number: +34625916595
- Email: IArtesero@santpau.cat
-
Córdoba, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofía
-
Contact:
- Patricia Cosano Perez
- Phone Number: +34633339548
- Email: patricia.cosano@imibic.org
-
Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon y Cajal
-
Contact:
- Celia Cano Sanz
- Phone Number: +34913369071
- Email: celiacanosz.ec@gmail.com
-
Seville, Spain, 41009
- Recruiting
- Hospital Universitario Virgen De La Macarena
-
Contact:
- Virginia Palomo Jimenez Palomo Jimenez
- Phone Number: +34955926553
- Email: virgi2015@hotmail.com
-
-
Barcelona
-
Badalona, Barcelona, Spain, 08916
- Recruiting
- Hospital Universitari Germans Trias I Pujol
-
Contact:
- Elena Abad
- Phone Number: +34 93 497 83 49
- Email: eabad@scienhub.org
-
Barcelona, Barcelona, Spain, 08907
- Recruiting
- Hospital Universitario de Bellvitge
-
Contact:
- Judit Orobitg Bernandes
- Phone Number: 34 93 260 75 00
- Email: orobitg@bellvitgehospital.cat
-
Terrassa, Barcelona, Spain, 08221
- Recruiting
- Hospital Universitario Mutua de Terrassa
-
Contact:
- Cristina Badia Marti
- Phone Number: +34937365050
- Email: cbadia@mutuaterrassa.cat
-
-
Guipúzcoa
-
San Sebastián, Guipúzcoa, Spain, 20014
- Recruiting
- H. U. Donostia
-
Contact:
- Claudia Nevado Pavón
- Phone Number: +34 943003535
- Email: claudia.nevadopavon@bio-gipuzkoa.eus
-
-
Madrid
-
Madrid, Madrid, Spain, 28007
- Recruiting
- Gregorio Marañón University Hospital
-
Contact:
- Sara Rodriguez
- Phone Number: +34915865492
- Email: sara.rodriguezinvestigacion@hotmail.com
-
Madrid, Madrid, Spain, 28046
- Recruiting
- Hospital Universitario La Paz - UCICEC
-
Contact:
- Ana Maria Ortega
- Phone Number: +34912071876
- Email: ana.ucicec@gmail.com
-
Majadahonda, Madrid, Spain, 28222
- Recruiting
- Hospital Universitario Puerta de Hierro Majadahonda
-
Contact:
- Paloma Rodríguez Araque
- Phone Number: +34911916481
- Email: farmacologia_clinica@idiphim.org
-
-
Sevilla
-
Seville, Sevilla, Spain, 41014
- Recruiting
- Hospital Universitario Virgen Macarena
-
Contact:
- María del Rocio Herrero del Río
- Phone Number: +34955015871
- Email: rocio.herrero.delrio@gmail.com
-
-
-
-
Kaohsiung
-
Kaohsiung City, Kaohsiung, Taiwan, 80756
- Recruiting
- KMU Chung-Ho Memorial Hospital
-
Contact:
- Yan-Zhen Hsu
- Phone Number: +886 963383335
- Email: hannah.hsu530@gmail.com
-
-
Taichung
-
Taichung, Taichung, Taiwan, 404327
- Recruiting
- China Medical University Hospital - Infectious
-
Contact:
- Ya Chun Tang
- Phone Number: +886 975297510
- Email: yachun620@gmail.com
-
-
Taoyuan
-
Taoyuan, Taoyuan, Taiwan, 333423
- Recruiting
- Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
-
Contact:
- Wen-Leng Chou
- Phone Number: 8848 88633281200
- Email: a5896067@yahoo.com.tw
-
-
-
-
-
Bournemouth, United Kingdom, BH7 7DW
- Withdrawn
- The Royal Bournemouth Hospital
-
Bristol, United Kingdom, BS10 5NB
- Recruiting
- North Bristol NHS Trust - Southmead Hospital, Clinical Research Centre
-
Contact:
- Kirstie Bradburn
- Phone Number: +4401174148102
- Email: Kirstie.Bradburn@nbt.nhs.uk
-
Edinburgh, United Kingdom, EH4 2XU
- Recruiting
- NHS Lothian - Western General Hospital
-
Contact:
- Amy Shepherd
- Phone Number: +4401315372840
- Email: Amy.shepherd@nhs.scot
-
London, United Kingdom, NW3 2QG
- Recruiting
- Royal Free London NHS Foundation Trust
-
Contact:
- Audrey Abdul
- Phone Number: +442074726446
- Email: Audrey.abdul@nhs.net
-
London, United Kingdom, SE1 7EH
- Recruiting
- St.Thomas' Hospital
-
Contact:
- Alieza Rara
- Phone Number: 53339 +4402071887188
- Email: Alieza.Rara@gstt.nhs.uk
-
Sheffield, United Kingdom, S5 7AU
- Recruiting
- Northern General Hospital
-
Contact:
- Priya Lata
- Phone Number: +4401142715779
- Email: priya.lata@nhs.net
-
Swansea, United Kingdom, SA6 6NL
- Recruiting
- Morriston Hospital
-
Contact:
- Elaine Brinkworth
- Phone Number: +4401792986806
- Email: Elaine.Brinkworth@wales.nhs.uk
-
-
Devon
-
Exeter, Devon, United Kingdom, EX2 5DW
- Withdrawn
- Royal Devon University Healthcare NHS Trust
-
-
-
-
Alabama
-
Huntsville, Alabama, United States, 35801
- Recruiting
- Metro Infectious Disease Consultants
-
Contact:
- Aundrea Bevis
- Phone Number: 256-469-7200
- Email: abevis@innovativeventures.com
-
-
Arizona
-
Chandler, Arizona, United States, 85224
- Withdrawn
- Advanced Gastroenterology, P.C.
-
Phoenix, Arizona, United States, 85054
- Withdrawn
- Mayo Clinic Hospital
-
Sun City, Arizona, United States, 85351
- Recruiting
- GI Alliance
-
Contact:
- Samuel Cordivin
- Phone Number: 1271 623-972-2116
- Email: scordivin@arizonadigestivehealth.com
-
-
California
-
Apple Valley, California, United States, 92307
- Withdrawn
- Om Research, LLC
-
Culver City, California, United States, 90230
- Recruiting
- Science 37 Inc (Remote/Home option)
-
Contact:
- Debra Weinstein, MD
- Phone Number: 323-815-7793
- Email: restorative303@science37.com
-
Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital of Los Angeles
-
Contact:
- Victor Yu
- Phone Number: 323-361-8481
- Email: vyu@chla.usc.edu
-
San Diego, California, United States, 92161
- Recruiting
- VA San Diego Healthcare System
-
Contact:
- David Looney, MD
- Phone Number: 2585 (858) 552-8585
- Email: David.Looney@va.gov
-
San Dimas, California, United States, 91773
- Withdrawn
- North America Research Institute
-
Thousand Oaks, California, United States, 91360
- Recruiting
- Clinical Trials Management Services
-
Contact:
- Teresa Tocher
- Phone Number: 805-906-7800
- Email: siteservices@clinicaltrialsmanagementservices.com
-
Torrance, California, United States, 90502
- Recruiting
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
Contact:
- Janine La Page
- Phone Number: 310-222-4104
- Email: jlapage@lundquist.org
-
-
Connecticut
-
Bristol, Connecticut, United States, 06010
- Recruiting
- Connecticut Clinical Research Institute
-
Contact:
- Cecile Guttermuth
- Phone Number: 860-585-3838
- Email: cguttermuth@connecticutgi.org
-
Hamden, Connecticut, United States, 06518
- Recruiting
- Medical Research Center of Connecticut
-
Contact:
- Candace Cotto
- Phone Number: 904-680-0871
- Email: ccotto@gastrocenter.org
-
Hartford, Connecticut, United States, 06102
- Withdrawn
- Hartford Hospital
-
-
Florida
-
Clearwater, Florida, United States, 33756
- Recruiting
- Gastro Florida
-
Contact:
- Tara Wasson-Olden
- Phone Number: 1 727-347-0005
- Email: tolden@gastrofl.com
-
Contact:
- Shannon Brewington
- Phone Number: 772-336-7682
- Email: sbrewington@gastrofl.com
-
Fort Lauderdale, Florida, United States, 33308
- Recruiting
- Proactive Clinical Research, LLC
-
Contact:
- Carolyn Zambrano
- Phone Number: 954-938-2843
- Email: czambrano@proactivecr.com
-
Jacksonville, Florida, United States, 32256
- Recruiting
- Encore Borland-Groover Clinical Research
-
Contact:
- Cynthia Buda
- Phone Number: 904-621-0390
- Email: cbuda@encoredocs.com
-
Naples, Florida, United States, 34102
- Recruiting
- GI Pros Research
-
Contact:
- Paula Allain
- Phone Number: 239-649-1336
- Email: pallainresearch@gmail.com
-
Port Orange, Florida, United States, 32127
- Recruiting
- Advanced Medical Research Center
-
Contact:
- Mohamed Alharami
- Phone Number: 386-767-8800
- Email: mhekmat@amrcus.com
-
Saint Cloud, Florida, United States, 34769
- Recruiting
- KM International Research Operation LLC
-
Contact:
- Kadidia Kone-Merchant
- Phone Number: 321-805-4774
- Email: kad@kminternationalresearchoperationllc.com
-
Tampa, Florida, United States, 33614
- Recruiting
- International Center for Research
-
Contact:
- Laura Porro
- Phone Number: 786-308-1157
- Email: Lporro@ICR-Health.org
-
Tampa, Florida, United States, 33612
- Recruiting
- James A. Haley Veterans' Hospital
-
Contact:
- John F Toney, MD
- Phone Number: 6697 813-972-2000
- Email: john.toney@va.gov
-
-
Georgia
-
Athens, Georgia, United States, 30607
- Recruiting
- Summit Clinical Research, LLC
-
Contact:
- Jeffrey Williams, MD
- Email: jwilliams@summitclinicalstudies.com
-
Atlanta, Georgia, United States, 30308
- Recruiting
- Emory University Hospital Midtown
-
Contact:
- Jennifer Truell
- Phone Number: 404-778-0014
- Email: jennifer.carter.truell@emory.edu
-
Contact:
- Nirja Mehta, MD
- Phone Number: 470-839-5804
- Email: nirja.mehta@emory.edu
-
Decatur, Georgia, United States, 30033
- Recruiting
- Metro Infectious Disease Consultants
-
Contact:
- Jaol Matos
- Email: jmatos@idsatlanta.com
-
La Grange, Georgia, United States, 30240
- Withdrawn
- Regional Infectious Diseases and Infusion Center, Inc.
-
Marietta, Georgia, United States, 30060
- Recruiting
- Gastrointestinal Specialists of Georgia
-
Contact:
- Octavia Nichols
- Phone Number: 678-819-4237
- Email: onichols@gigeorgia.com
-
-
Idaho
-
Idaho Falls, Idaho, United States, 83404
- Recruiting
- Snake River Research, PLLC
-
Contact:
- Jennifer Morrison
- Phone Number: 208-535-8406
- Email: jmorrison@snakerr.com
-
-
Illinois
-
Burr Ridge, Illinois, United States, 60527
- Recruiting
- Metro Infectious Disease Consultants
-
Contact:
- Sarah Arnold
- Phone Number: 630-655-8441
- Email: sarnold@innovativeventures.com
-
Evanston, Illinois, United States, 60201
- Withdrawn
- NorthShore University Health System - Evanston Hospital
-
Gurnee, Illinois, United States, 60031
- Recruiting
- GI Alliance
-
Contact:
- Emma Lamblin
- Phone Number: 224-441-2217
- Email: Emma.Lamblin@gialliance.com
-
Island Lake, Illinois, United States, 60042
- Withdrawn
- Innovative Clinical Research Center, LLC (ICRC)
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University Health University Hospital
-
Contact:
- Debbie Drenzyk
- Phone Number: 317-948-9212
- Email: iuibd@iupui.edu
-
Contact:
- Renee Hewitt
- Phone Number: 317-278-9294
- Email: iuibd@iupui.edu
-
New Albany, Indiana, United States, 47150
- Recruiting
- Gastroenterology Health Partners
-
Contact:
- Brandon Daly
- Phone Number: (812) 945-0145
- Email: Brandy.Daly@onegi.com
-
Newburgh, Indiana, United States, 47630
- Withdrawn
- Deaconess GI Specialty Center
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
-
Contact:
- Melissa Willer
- Phone Number: 913-945-6770
- Email: mwiller@kumc.edu
-
Contact:
- KUMC Research Administration
- Email: researchadministration@kumc.edu
-
Wichita, Kansas, United States, 67211
- Withdrawn
- IDC Clinical Research, LLC
-
-
Kentucky
-
Louisville, Kentucky, United States, 40218
- Recruiting
- Gastroenterology Health Partners
-
Contact:
- Brandon Daly
- Phone Number: (812) 945-0145
- Email: Brandy.Daly@onegi.com
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Ochsner Clinic Foundation
-
Contact:
- Julie Castex
- Phone Number: 504-842-7154
- Email: jcastex@ochsner.org
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins Hospital
-
Contact:
- Zoey Onambele
- Phone Number: 410-955-6337
- Email: zonambe1@jhu.edu
-
Contact:
- Sean Anderson
- Phone Number: 410-955-6337
- Email: sande145@jhu.edu
-
Chevy Chase, Maryland, United States, 20815
- Recruiting
- MGG Group Co., Inc., Chevy Chase Clinical Research
-
Contact:
- Gilbert Horst
- Phone Number: 301-652-5520
- Email: ghorst@jointopo.com
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
-
Contact:
- Grace Hardwick
- Phone Number: 617-525-7011
- Email: ghardwick@bwh.harvard.edu
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Elizabeth Hohmann, MD
- Phone Number: 617-724-7432
- Email: ehohmann@mgh.harvard.edu
-
Boston, Massachusetts, United States, 02111
- Withdrawn
- Tufts Medical Center
-
Newton, Massachusetts, United States, 02462
- Withdrawn
- Newton-Wellesley Hospital
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- Recruiting
- LTC Charles S. Kettles VA Medical Center
-
Contact:
- Kimberly Nofz
- Phone Number: 734-845-5522
- Email: kimberly.nofz@va.gov
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health
-
Contact:
- Anita Shallal, MD
- Phone Number: 313-850-7032
- Email: ashalla2@hfhs.org
-
Royal Oak, Michigan, United States, 48073
- Recruiting
- Corewell Health William Beaumont University Hospital
-
Contact:
- Maureen Cooney
- Phone Number: 248-551-2544
- Email: Maureen.Cooney@corewellhealth.org
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota Medical Center
-
Contact:
- Makenzie Richard
- Phone Number: 612-625-8090
- Email: rich1400@umn.edu
-
Plymouth, Minnesota, United States, 55446
- Withdrawn
- MNGI Digestive Health, PA
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Contact:
- Patricia Kramer
- Phone Number: 507-538-1827
- Email: kammer.patricia@mayo.edu
-
-
Mississippi
-
Southaven, Mississippi, United States, 38671
- Withdrawn
- Delta Gastroenterology and Endoscopy Center
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- Withdrawn
- University of Missouri
-
St Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
-
Contact:
- Teresa Arb
- Phone Number: 314-747-1217
- Email: arbt@wustl.edu
-
Weldon Spring, Missouri, United States, 63304
- Recruiting
- St. Charles Clinical Research
-
Contact:
- Kelly Moushey
- Email: k.moushey@stcharlesclinicalresearch.com
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Robert Wood Johnson Medical School
-
Contact:
- Therese Pagulayan
- Phone Number: 732-235-6128
- Email: tup1@rwjms.rutgers.edu
-
Somers Point, New Jersey, United States, 08244
- Recruiting
- South Jersey Infectious Disease
-
Contact:
- Kelly Freeman
- Phone Number: 5 609-927-6662
- Email: kelly.freeman@sjidtrials.net
-
-
New York
-
Manhasset, New York, United States, 11030
- Recruiting
- Northwell Health Division of Infectious Diseases
-
Contact:
- Jessica Rao
- Phone Number: 516-562-3363
- Email: JCabildo@Northwell.edu
-
Contact:
- Andrew Diaz
- Email: adiaz34@northwell.edu
-
New York, New York, United States, 10021
- Recruiting
- New York Presbyterian Hospital
-
Contact:
- Tiffany Min
- Phone Number: 646-962-4463
- Email: tim9064@med.cornell.edu
-
New York, New York, United States, 10016
- Recruiting
- NYU Grossman school of Medicine
-
Contact:
- Nathasha Melukkaran
- Phone Number: 646-754-3417
- Email: Nathasha.melukkaran@nyulangone.org
-
New York, New York, United States, 10279
- Withdrawn
- Manhattan Clinical Research, LLC
-
Syracuse, New York, United States, 13210
- Terminated
- Syracuse VA Medical Center
-
The Bronx, New York, United States, 10467
- Terminated
- Montefiore Medical Center
-
-
Ohio
-
Toledo, Ohio, United States, 43617
- Withdrawn
- Toledo Institute of Clinical Research
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Active, not recruiting
- Oklahoma City Veterans Affairs Healthcare System
-
-
Pennsylvania
-
Harrisburg, Pennsylvania, United States, 17110
- Recruiting
- Susquehanna Research Group - Gastroenterology
-
Contact:
- Jessica Balay
- Phone Number: 717-914-7770
- Email: jbalay@gicare.com
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- Kelly Menna
- Phone Number: 215-590-3669
- Email: mennak@chop.edu
-
Sayre, Pennsylvania, United States, 18840
- Withdrawn
- Guthrie Medical Group, PC
-
Uniontown, Pennsylvania, United States, 15401
- Recruiting
- Frontier Clinical Research
-
Contact:
- Kim Chapman
- Phone Number: 724-596-8036
- Email: kchapman@frontierclinical.com
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Contact:
- Alicia Hartley
- Phone Number: 843-792-4100
- Email: hartleal@musc.edu
-
Charleston, South Carolina, United States, 29401
- Withdrawn
- Ralph H. Johnson VA Health Care System
-
Charleston, South Carolina, United States, 29414
- Withdrawn
- Lowcountry Infectious Diseases, P.A.
-
-
Tennessee
-
Cordova, Tennessee, United States, 38018
- Recruiting
- Gastro One Research
-
Contact:
- Stephanie Bhula
- Phone Number: 901-309-6031
- Email: sbhula@gastro1.com
-
Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University Medical Center
-
Contact:
- Emily Cleveland
- Phone Number: 615-396-0177
- Email: emily.f.cleveland@vumc.org
-
-
Texas
-
Cedar Park, Texas, United States, 78613
- Recruiting
- GI Alliance
-
Contact:
- Alexa Payne
- Phone Number: 512-341-0900
- Email: Alexa.Payne@GiAlliance.com
-
Dallas, Texas, United States, 75246
- Recruiting
- North Texas Infectious Disease Consultants, P.A.
-
Contact:
- Jessica Caldwell
- Phone Number: 214-823-2533
- Email: jessica.caldwell@ntidc.org
-
Houston, Texas, United States, 77204
- Withdrawn
- University of Houston College of Pharmacy
-
Katy, Texas, United States, 77494
- Withdrawn
- BioStar Clinical Research
-
Lubbock, Texas, United States, 79410
- Recruiting
- GI Alliance
-
Contact:
- Chase Mosley
- Phone Number: 806-793-3141
- Email: chase.mosley@gialliance.com
-
Sugar Land, Texas, United States, 77478
- Withdrawn
- Simcare Medical Research, LLC
-
-
Virginia
-
Richmond, Virginia, United States, 23229
- Recruiting
- GI Alliance
-
Contact:
- Kristy Satkowski
- Phone Number: 804-362-0954
- Email: Kristy.Satkowski@gastrova.com
-
-
Washington
-
Seattle, Washington, United States, 98101
- Recruiting
- Virginia Mason Medical Center
-
Contact:
- Emily Chesterfield
- Phone Number: 206-341-1416
- Email: emily.chesterfield@commonspirit.org
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Seattle, Washington, United States, 98101
- Withdrawn
- Seattle Infectious Disease Clinic
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53207
- Recruiting
- Wisconsin Center for Advanced Research
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Contact:
- Lisa Cannon
- Phone Number: 414-908-6630
- Email: lisac@wigia.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population):
- Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months
Key Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):
- Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI
OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:
- Age ≥ 65 years
- Kidney dysfunction, defined as estimated creatinine clearance < 60 mL/min/1.73 m^2 at the time of the qualifying CDI episode
- 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
- History of a prior CDI episode between 6 and 12 months prior to enrollment
- Immunosuppression due to an underlying disease or its treatment
- Has undergone solid organ or hematopoietic stem cell transplantation
Key Inclusion Criteria (For enrollment in Stage 1 or 2):
The qualifying episode of CDI must meet all the following criteria:
- 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:
- 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
Key Exclusion Criteria (For both Stage 1 and Stage 2):
- History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI
- Known or suspected toxic megacolon or small bowel ileus at the time of randomization
- History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis
- Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode
- Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug
- Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)
- Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt, kombucha, and kefir are permitted.)
- Absolute neutrophil count (ANC) of < 0.5 ×10^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC < 1.0 × 10^9 cells/L
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VE303
Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
|
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 Comparator: Placebo
Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CDI Recurrence Rate at Week 8
Time Frame: 8 weeks
|
Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
October 1, 2027
Study Registration Dates
First Submitted
January 23, 2024
First Submitted That Met QC Criteria
January 23, 2024
First Posted (Actual)
February 1, 2024
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
May 13, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VE303-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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