Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

February 8, 2019

Primary Completion Date

June 2, 2021

Study Completion Date

September 15, 2021

Conditions
Clostridium Difficile Infection RecurrenceClostridium Difficile InfectionClostridium DifficileClostridioides Difficile Infection RecurrenceClostridioides Difficile InfectionClostridioides DifficileCDI
Interventions
DRUG

VE303

VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions.

DRUG

Placebo

Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product.

Trial Locations (37)

10016

New York University Langone Medical Center, New York

15401

Frontier Clinical Research, LLC, Uniontown

15801

TruCare Internal Medicine and Infectious Diseases, DuBois

21401

Anne Arundel Health System Research Insitute, Annapolis

24501

Infectious Disease Associates of Central Virginia Infectious Disease, Lynchburg

27103

Southeastern Research Center, Winston-Salem

28054

Clinical Research of Gastonia, Gastonia

32610

University of Florida, Gainesville

33614

Guardian Angel Research Center, Tampa

33756

Innovative Research of West Florida, Clearwater

33765

Gastro Florida, Clearwater

43617

Toledo Institute of Clinical Research Inc, Toledo

48604

Covenant HealthCare, Saginaw

55906

Mayo Clinic, Rochester

72401

NEA Baptist Clinic, Jonesboro

75007

Clinrx Research Joseph INC, Plano

76104

Texas Centers for Infectious Disease Associates, Fort Worth

78613

Advanced Clinical Research-Be Well MD, Cedar Park

85014

Phoenix Clinical, LLC, Phoenix

85054

Mayo Clinic, Clinical Studies Unit, Phoenix

91304

Alliance Research Institute, Canoga Park

93003

Ventura Clinical Trials, Ventura

95817

University of California, Davis Medical Center, Sacramento

98101

Seattle Infectious Disease Clinic, Seattle

99202

Advanced Clinical Research-Spokane Gastroenterology, Spokane

06518

Medical Research Center of Connecticut, LLC, Hamden

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

T2N2T9

Foothills Medical Centre - Microbial Health Clinic, Calgary

T4N6V7

CARe Clinic, Red Deer

E1C6Z8

Moncton Hospital, Moncton

L8N4A6

St. Joseph's Healthcare Hamilton, Hamilton

M1P2T7

Viable Clinical Research, Scarborough Village

G7H7Y8

Q&T Research Chicoutimi, Chicoutimi

G1V 4G2

CHU de Québec-Université Laval, Québec

G8Z3R9

Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-, Trois-Rivières

All Listed Sponsors
lead

Vedanta Biosciences, Inc.

INDUSTRY

NCT03788434 - Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection | Biotech Hunter | Biotech Hunter