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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VE303 High Dose | Experimental | Study subjects assigned the high dose VE303 arm took 10 capsules (dosage: 8.0 × 10^9 CFU daily) containing VE303 per day for 14 days. |
|
| VE303 Low Dose | Experimental | Study subjects assigned to the low dose VE303 arm took 2 capsules (dosage: 1.6 × 10^9 CFU daily) containing VE303 per day for 14 days. |
|
| Placebo | Placebo Comparator | Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VE303 | Drug | VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under Good Manufacturing Practices (GMP) conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VE303 Strains Detected | Characterize the number of VE303 strains detected in the fecal microbiome at week 24. | 24 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| CDI Recurrence Week 12 |
Partial Inclusion Criteria:
Partial Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darrell Pardi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Clinical, LLC | Phoenix | Arizona | 85014 | United States | ||
| Mayo Clinic, Clinical Studies Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37060545 | Derived | Louie T, Golan Y, Khanna S, Bobilev D, Erpelding N, Fratazzi C, Carini M, Menon R, Ruisi M, Norman JM, Faith JJ, Olle B, Li M, Silber JL, Pardi DS. VE303, a Defined Bacterial Consortium, for Prevention of Recurrent Clostridioides difficile Infection: A Randomized Clinical Trial. JAMA. 2023 Apr 25;329(16):1356-1366. doi: 10.1001/jama.2023.4314. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VE303 High Dose | Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. |
| FG001 | VE303 Low Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2021 | Mar 16, 2023 |
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This Phase 2 study evaluated the safety and efficacy of the study drug, VE303, at preventing subsequent CDI-associated diarrhea compared with placebo, following completion of at least 1 successful course of SOC antibiotics for subjects with pCDI at high risk for recurrence or subjects with rCDI.
Participants in the study were randomized into 3 arms in a 1:1:1 ratio of high dose VE303, low dose VE303, and placebo.
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To reduce potential bias and increase study data integrity, study participants, care providers, site investigators, and study outcomes assessors were masked to study treatment assignment.
| Placebo | Drug | Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. Placebo capsules did not contain any VE303 Drug Product. |
|
| 24 weeks |
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 |
| 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 |
| Microbiota Diversity | Characterize the fecal microbiome Shannon Diversity at week 24. | 24 weeks |
| 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 |
| 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 |
| Taxonomic Composition | Characterize Taxonomic Composition | 31 Months, 1 Week |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | United States |
| Alliance Research Institute | Canoga Park | California | 91304 | United States |
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| Ventura Clinical Trials | Ventura | California | 93003 | United States |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | United States |
| Gastro Florida | Clearwater | Florida | 33765 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Guardian Angel Research Center | Tampa | Florida | 33614 | United States |
| Anne Arundel Health System Research Insitute | Annapolis | Maryland | 21401 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Covenant HealthCare | Saginaw | Michigan | 48604 | United States |
| Mayo Clinic | Rochester | Minnesota | 55906 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Toledo Institute of Clinical Research Inc | Toledo | Ohio | 43617 | United States |
| TruCare Internal Medicine and Infectious Diseases | DuBois | Pennsylvania | 15801 | United States |
| Frontier Clinical Research, LLC | Uniontown | Pennsylvania | 15401 | United States |
| Advanced Clinical Research-Be Well MD | Cedar Park | Texas | 78613 | United States |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| Clinrx Research Joseph INC | Plano | Texas | 75007 | United States |
| Infectious Disease Associates of Central Virginia Infectious Disease | Lynchburg | Virginia | 24501 | United States |
| Seattle Infectious Disease Clinic | Seattle | Washington | 98101 | United States |
| Advanced Clinical Research-Spokane Gastroenterology | Spokane | Washington | 99202 | United States |
| Foothills Medical Centre - Microbial Health Clinic | Calgary | Alberta | T2N2T9 | Canada |
| CARe Clinic | Red Deer | Alberta | T4N6V7 | Canada |
| Moncton Hospital | Moncton | New Brunswick | E1C6Z8 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N4A6 | Canada |
| Viable Clinical Research | Scarborough Village | Ontario | M1P2T7 | Canada |
| Q&T Research Chicoutimi | Chicoutimi | Quebec | G7H7Y8 | Canada |
| CHU de Québec-Université Laval | Québec | Quebec | G1V 4G2 | Canada |
| Centre intégré universitaire de santé et de services sociaux de la Mauricie-et- | Trois-Rivières | Quebec | G8Z3R9 | Canada |
Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. |
| FG002 | Placebo | Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VE303 High Dose | Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. |
| BG001 | VE303 Low Dose | Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. |
| BG002 | Placebo | Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | 8 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | VE303 Strains Detected | Characterize the number of VE303 strains detected in the fecal microbiome at week 24. | Enrolled subjects who provided stool samples for analysis at week 24. | Posted | Mean | Standard Deviation | Number of VE303 strains detected | 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. | Enrolled subjects who provided stool samples for analysis at week 24. | Posted | Mean | Standard Deviation | Proportion of VE303 strains | 24 weeks |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Posted | Count of Participants | Participants | 4 Weeks |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Posted | Count of Participants | Participants | 12 Weeks |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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). | Posted | Count of Participants | Participants | 24 Weeks |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Microbiota Diversity | Characterize the fecal microbiome Shannon Diversity at week 24. | Not Posted | 24 weeks | Participants | |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Not Posted | 31 Months 1 Week | Participants | |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Not Posted | 31 Months 1 Week | Participants | |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Taxonomic Composition | Characterize Taxonomic Composition | Not Posted | 31 Months, 1 Week | Participants |
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VE303 High Dose | Study subjects assigned to the high dose VE303 arm took 10 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. | 0 | 29 | 1 | 29 | 28 | 29 |
| EG001 | VE303 Low Dose | Study subjects assigned to the low dose VE303 arm took 2 capsules containing VE303 per day for 14 days. VE303: VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions. | 0 | 27 | 4 | 27 | 27 | 27 |
| EG002 | Placebo | Study subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303. Placebo: Placebo capsules contained microcrystalline cellulose and were visually identical to VE303 capsules. | 0 | 22 | 2 | 22 | 21 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Lower | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| CDI | Infections and infestations | Non-systematic Assessment |
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| Escherichia Bacteraemia | Infections and infestations | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
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| Transfusion Reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain Lower | Gastrointestinal disorders | Non-systematic Assessment |
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| Irritable Bowel Syndrome | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Pyrexia | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | Non-systematic Assessment |
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| Malaise | General disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Blood Potassium Increased | Investigations | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Silber | Vedanta Biosciences | (857) 706-1427 | ConsortiumIO-ctinquiries@vedantabio.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2021 | Mar 16, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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| C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated) |
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