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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03788434
Other study ID # CONSORTIUM (VE303-002)
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 8, 2019
Est. completion date September 15, 2021

Study information

Verified date June 2023
Source Vedanta Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).


Description:

CONSORTIUM was a randomized, placebo-controlled double-blind Phase 2 study to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of VE303 in prevention of subsequent Clostridioides difficile infection (CDI) -associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. VE303 or placebo capsules were taken orally for 14 days after completion of a course of SOC antibiotics. The proportions of subjects experiencing a confirmed CDI recurrence within 8 weeks after the first dose of study treatment were compared across the study arms, to understand the efficacy of VE303 in preventing rCDI. The study originally planned to enroll 146 subjects but through a protocol amendment was revised to an enrollment target of 60 to 80 subjects with a prior history of CDI diarrhea or first occurrence of CDI diarrhea with a higher risk for recurrence. Subjects must have had a positive C. difficile stool sample and have responded to SOC antibiotic treatment.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date September 15, 2021
Est. primary completion date June 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Partial Inclusion Criteria: 1. Able and willing to provide written informed consent 2. Subjects with a qualifying CDI episode who had a prior history of CDI diarrhea (= 18 years of age) or first occurrence of CDI diarrhea with a higher risk for recurrence (= 75 years of age, or = 65 years of age with one or more prespecified conditions) 3. CDI symptoms must have started within 30 days (inclusive) prior to the day of randomization 4. The diarrhea was considered unlikely to have another etiology. 5. Completed an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and up to 21 days of total duration 6. Have a positive C. difficile stool 7. Recovered from any complications of severe or fulminant CDI and clinically stable by the time of randomization. Partial Exclusion Criteria: 1. History of diarrhea (defined as 3 or more loose stools per day lasting for at least 4 weeks) that was not related to C. difficile infection within the 3 months prior to randomization. 2. Known or suspected toxic megacolon and/or known small bowel ileus at the time of randomization. 3. Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting, or ileus). 4. Prior administration of genetically modified investigational live bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea 5. History of administration of fecally-derived investigational live biotherapeutic products, or fecally-derived live bacterial isolates for CDI-associated diarrhea including fecal microbiota transplantation (FMT) within the last 6 months. 6. Use of drugs that alter gut motility 7. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization. 8. Subjects with compromised immune system 9. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within 3 months prior to randomization or any history of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen. 10. History of confirmed celiac disease, inflammatory bowel disease, short gut, gastrointestinal tract fistulas, or ischemia.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VE303
VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions.
Placebo
Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product.

Locations

Country Name City State
Canada Foothills Medical Centre - Microbial Health Clinic Calgary Alberta
Canada Q&T Research Chicoutimi Chicoutimi Quebec
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario
Canada Moncton Hospital Moncton New Brunswick
Canada CHU de Québec-Université Laval Quebec City Quebec
Canada CARe Clinic Red Deer Alberta
Canada Viable Clinical Research Scarborough Ontario
Canada Centre intégré universitaire de santé et de services sociaux de la Mauricie-et- Trois-Rivières Quebec
United States Anne Arundel Health System Research Insitute Annapolis Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States Alliance Research Institute Canoga Park California
United States Advanced Clinical Research-Be Well MD Cedar Park Texas
United States Gastro Florida Clearwater Florida
United States Innovative Research of West Florida Clearwater Florida
United States TruCare Internal Medicine and Infectious Diseases DuBois Pennsylvania
United States Texas Centers for Infectious Disease Associates Fort Worth Texas
United States University of Florida Gainesville Florida
United States Clinical Research of Gastonia Gastonia North Carolina
United States Medical Research Center of Connecticut, LLC Hamden Connecticut
United States NEA Baptist Clinic Jonesboro Arkansas
United States Infectious Disease Associates of Central Virginia Infectious Disease Lynchburg Virginia
United States New York University Langone Medical Center New York New York
United States Mayo Clinic, Clinical Studies Unit Phoenix Arizona
United States Phoenix Clinical, LLC Phoenix Arizona
United States Clinrx Research Joseph INC Plano Texas
United States Mayo Clinic Rochester Minnesota
United States University of California, Davis Medical Center Sacramento California
United States Covenant HealthCare Saginaw Michigan
United States Seattle Infectious Disease Clinic Seattle Washington
United States Advanced Clinical Research-Spokane Gastroenterology Spokane Washington
United States Guardian Angel Research Center Tampa Florida
United States Toledo Institute of Clinical Research Inc Toledo Ohio
United States Frontier Clinical Research, LLC Uniontown Pennsylvania
United States Ventura Clinical Trials Ventura California
United States Southeastern Research Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Vedanta Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other CDI Recurrence Week 4 Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 4 (i.e., 4 weeks after the first dose of study treatment). 4 Weeks
Other CDI Recurrence Week 12 Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 12 (i.e., 12 weeks after the first dose of study treatment). 12 Weeks
Other CDI Recurrence Week 24 Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 24 (i.e., 24 weeks after the first dose of study treatment). 24 Weeks
Other Microbiota Diversity Characterize the fecal microbiome Shannon Diversity at week 24. 24 weeks
Other Determine the Recommended VE303 Phase 3 Dose Regimen(s). Determine the recommended VE303 phase 3 dose regimen(s) based on safety and efficacy, as indicated by the CDI recurrence rate for the duration of the study. 31 Months 1 Week
Other Changes in the Fecal Metabolomic Profile, Including Short-chain Fatty Acids and Bile Acids. Changes in the fecal metabolomic profile, including short-chain fatty acids and bile acids for the duration of the study. 31 Months 1 Week
Other Taxonomic Composition Characterize Taxonomic Composition 31 Months, 1 Week
Primary CDI Recurrence Week 8 Percentage of participants with toxin-positive, laboratory-confirmed, or clinically diagnosed and treated CDI recurrence before or at Week 8 (i.e., 8 weeks after the first dose of study treatment). 8 weeks
Secondary VE303 Strains Detected Characterize the number of VE303 strains detected in the fecal microbiome at week 24. 24 weeks
Secondary VE303 Relative Abundance Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample. 24 weeks
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