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Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection (CONSORTIUM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788434
Recruitment Status : Completed
First Posted : December 27, 2018
Results First Posted : July 3, 2023
Last Update Posted : July 3, 2023
Sponsor:
Information provided by (Responsible Party):
Vedanta Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection
Clostridium Difficile
Clostridioides Difficile Infection Recurrence
Clostridioides Difficile Infection
Clostridioides Difficile
CDI
Interventions Drug: VE303
Drug: Placebo
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description

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.

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.

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.
Period Title: Overall Study
Started 30 27 22
Completed 29 27 22
Not Completed 1 0 0
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo Total
Hide Arm/Group Description

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.

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.

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.

 Total of all reporting groups
Overall Number of Baseline Participants 30 27 22 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 22 participants 79 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  53.3%
12
  44.4%
12
  54.5%
40
  50.6%
>=65 years
14
  46.7%
15
  55.6%
10
  45.5%
39
  49.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 27 participants 22 participants 79 participants
62.3  (14.99) 62.9  (17.85) 60.8  (15.98) 62.1  (16.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 22 participants 79 participants
Female
19
  63.3%
20
  74.1%
17
  77.3%
56
  70.9%
Male
11
  36.7%
7
  25.9%
5
  22.7%
23
  29.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 22 participants 79 participants
Hispanic or Latino
2
   6.7%
0
   0.0%
0
   0.0%
2
   2.5%
Not Hispanic or Latino
28
  93.3%
27
 100.0%
22
 100.0%
77
  97.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 22 participants 79 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.3%
0
   0.0%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   3.7%
0
   0.0%
1
   1.3%
White
29
  96.7%
25
  92.6%
22
 100.0%
76
  96.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.7%
0
   0.0%
1
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 30 participants 27 participants 22 participants 79 participants
United States 18 17 14 49
Canada 12 10 8 30
1.Primary Outcome
Title CDI Recurrence Week 8
Hide Description 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).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description:

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.

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.

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.
Overall Number of Participants Analyzed 29 27 22
Measure Type: Count of Participants
Unit of Measure: Participants
C. difficile recurrences (toxin-positive)
4
  13.8%
9
  33.3%
5
  22.7%
C. difficile recurrences (laboratory-confirmed)
4
  13.8%
10
  37.0%
8
  36.4%
C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)
4
  13.8%
10
  37.0%
10
  45.5%
2.Secondary Outcome
Title VE303 Strains Detected
Hide Description Characterize the number of VE303 strains detected in the fecal microbiome at week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects who provided stool samples for analysis at week 24.
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description:

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.

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.

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.
Overall Number of Participants Analyzed 20 21 14
Mean (Standard Deviation)
Unit of Measure: Number of VE303 strains detected
3.25  (2.807) 1.62  (1.962) 0.36  (0.633)
3.Secondary Outcome
Title VE303 Relative Abundance
Hide Description Proportion of VE303 strains is defined as the abundance proportion of all 8 VE303 strains relative to the total microbial composition of the sample.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects who provided stool samples for analysis at week 24.
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description:

Study subjects assigned 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.

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.

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.
Overall Number of Participants Analyzed 20 21 14
Mean (Standard Deviation)
Unit of Measure: Proportion of VE303 strains
0.01186  (0.013897) 0.00775  (0.016007) 0.00097  (0.002297)
4.Other Pre-specified Outcome
Title CDI Recurrence Week 4
Hide Description 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).
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description:

Study subjects assigned 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.

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.

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.
Overall Number of Participants Analyzed 29 27 22
Measure Type: Count of Participants
Unit of Measure: Participants
C. difficile recurrences (toxin-positive)
4
  13.8%
9
  33.3%
2
   9.1%
C. difficile recurrences (laboratory-confirmed)
4
  13.8%
10
  37.0%
5
  22.7%
C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)
4
  13.8%
10
  37.0%
6
  27.3%
5.Other Pre-specified Outcome
Title CDI Recurrence Week 12
Hide Description 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).
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description:

Study subjects assigned 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.

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.

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.
Overall Number of Participants Analyzed 29 27 22
Measure Type: Count of Participants
Unit of Measure: Participants
C. difficile recurrences (toxin-positive)
4
  13.8%
9
  33.3%
5
  22.7%
C. difficile recurrences (laboratory-confirmed)
4
  13.8%
10
  37.0%
8
  36.4%
C. difficile recurrences (laboratory-confirmed, or clinically diagnosed and treated)
4
  13.8%
10
  37.0%
10
  45.5%
6.Other Pre-specified Outcome
Title CDI Recurrence Week 24
Hide Description 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).
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description:

Study subjects assigned 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.

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.

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.
Overall Number of Participants Analyzed 29 27 22
Measure Type: Count of Participants
Unit of Measure: Participants
C. difficile recurrences (toxin-positive)
4
  13.8%
9
  33.3%
5
  22.7%
C. difficile recurrences (laboratory-confirmed)
5
  17.2%
11
  40.7%
8
  36.4%
C. difficile recurrences (laboratory-confirmed or clinically diagnosed and treated)
5
  17.2%
11
  40.7%
10
  45.5%
7.Other Pre-specified Outcome
Title Microbiota Diversity
Hide Description Characterize the fecal microbiome Shannon Diversity at week 24.
Time Frame 24 weeks
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Determine the Recommended VE303 Phase 3 Dose Regimen(s).
Hide Description 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.
Time Frame 31 Months 1 Week
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Changes in the Fecal Metabolomic Profile, Including Short-chain Fatty Acids and Bile Acids.
Hide Description Changes in the fecal metabolomic profile, including short-chain fatty acids and bile acids for the duration of the study.
Time Frame 31 Months 1 Week
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Taxonomic Composition
Hide Description Characterize Taxonomic Composition
Time Frame 31 Months, 1 Week
Outcome Measure Data Not Reported
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VE303 High Dose VE303 Low Dose Placebo
Hide Arm/Group Description

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.

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.

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.
All-Cause Mortality
VE303 High Dose VE303 Low Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/27 (0.00%)      0/22 (0.00%)    
Hide Serious Adverse Events
VE303 High Dose VE303 Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      4/27 (14.81%)      2/22 (9.09%)    
Gastrointestinal disorders       
Abdominal Pain Lower *  0/29 (0.00%)  0 0/27 (0.00%)  0 1/22 (4.55%)  1
Nausea *  0/29 (0.00%)  0 0/27 (0.00%)  0 1/22 (4.55%)  1
Vomiting *  0/29 (0.00%)  0 0/27 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations       
CDI *  0/29 (0.00%)  0 1/27 (3.70%)  1 0/22 (0.00%)  0
Escherichia Bacteraemia *  0/29 (0.00%)  0 0/27 (0.00%)  0 1/22 (4.55%)  1
Pyelonephritis *  0/29 (0.00%)  0 0/27 (0.00%)  0 1/22 (4.55%)  1
Injury, poisoning and procedural complications       
Transfusion Reaction *  1/29 (3.45%)  1 0/27 (0.00%)  0 0/22 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast Cancer *  0/29 (0.00%)  0 1/27 (3.70%)  1 0/22 (0.00%)  0
Nervous system disorders       
Cerebrovascular Accident *  0/29 (0.00%)  0 1/27 (3.70%)  1 0/22 (0.00%)  0
Dizziness *  0/29 (0.00%)  0 1/27 (3.70%)  1 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease *  0/29 (0.00%)  0 1/27 (3.70%)  1 0/22 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VE303 High Dose VE303 Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/29 (96.55%)      27/27 (100.00%)      21/22 (95.45%)    
Gastrointestinal disorders       
Diarrhea *  21/29 (72.41%)  243 23/27 (85.19%)  213 19/22 (86.36%)  114
Nausea *  6/29 (20.69%)  7 6/27 (22.22%)  6 2/22 (9.09%)  2
Abdominal Pain *  5/29 (17.24%)  7 2/27 (7.41%)  2 2/22 (9.09%)  2
Vomiting *  1/29 (3.45%)  2 4/27 (14.81%)  4 3/22 (13.64%)  3
Abdominal Distension *  2/29 (6.90%)  3 1/27 (3.70%)  2 2/22 (9.09%)  2
Flatulence *  2/29 (6.90%)  2 1/27 (3.70%)  1 2/22 (9.09%)  2
Constipation *  3/29 (10.34%)  3 1/27 (3.70%)  1 0/22 (0.00%)  0
Dyspepsia *  1/29 (3.45%)  1 2/27 (7.41%)  2 1/22 (4.55%)  1
Abdominal Pain Lower *  0/29 (0.00%)  0 0/27 (0.00%)  0 3/22 (13.64%)  4
Irritable Bowel Syndrome *  2/29 (6.90%)  2 1/27 (3.70%)  1 0/22 (0.00%)  0
Abdominal Discomfort *  0/29 (0.00%)  0 2/27 (7.41%)  2 0/22 (0.00%)  0
Abdominal Pain Upper *  2/29 (6.90%)  2 0/27 (0.00%)  0 0/22 (0.00%)  0
Eructation *  0/29 (0.00%)  0 2/27 (7.41%)  2 0/22 (0.00%)  0
General disorders       
Chills *  2/29 (6.90%)  2 2/27 (7.41%)  2 0/22 (0.00%)  0
Pyrexia *  0/29 (0.00%)  0 4/27 (14.81%)  4 0/22 (0.00%)  0
Fatigue *  2/29 (6.90%)  2 1/27 (3.70%)  1 0/22 (0.00%)  0
Oedema Peripheral *  0/29 (0.00%)  0 1/27 (3.70%)  1 2/22 (9.09%)  2
Malaise *  0/29 (0.00%)  0 2/27 (7.41%)  2 0/22 (0.00%)  0
Infections and infestations       
Urinary Tract Infection *  1/29 (3.45%)  1 2/27 (7.41%)  2 4/22 (18.18%)  4
Injury, poisoning and procedural complications       
Fall *  0/29 (0.00%)  0 2/27 (7.41%)  2 0/22 (0.00%)  0
Investigations       
Blood Potassium Increased *  2/29 (6.90%)  2 0/27 (0.00%)  0 0/22 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration *  1/29 (3.45%)  1 2/27 (7.41%)  2 0/22 (0.00%)  0
Nervous system disorders       
Headache *  2/29 (6.90%)  2 3/27 (11.11%)  3 0/22 (0.00%)  0
Dizziness *  0/29 (0.00%)  0 3/27 (11.11%)  3 1/22 (4.55%)  1
Dysgeusia *  2/29 (6.90%)  3 0/27 (0.00%)  0 2/22 (9.09%)  2
Respiratory, thoracic and mediastinal disorders       
Cough *  1/29 (3.45%)  1 2/27 (7.41%)  2 0/22 (0.00%)  0
Oropharyngeal Pain *  0/29 (0.00%)  0 0/27 (0.00%)  0 2/22 (9.09%)  2
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Silber
Organization: Vedanta Biosciences
Phone: (857) 706-1427
EMail: ConsortiumIO-ctinquiries@vedantabio.com
Layout table for additonal information
Responsible Party: Vedanta Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03788434    
Other Study ID Numbers: CONSORTIUM (VE303-002)
First Submitted: December 19, 2018
First Posted: December 27, 2018
Results First Submitted: August 29, 2022
Results First Posted: July 3, 2023
Last Update Posted: July 3, 2023