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Clostridium Difficile Infection RecurrencePhase 2CONSORTIUMNCT03788434

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

A Phase 2 study testing VE303 in people with Clostridium Difficile Infection Recurrence and Clostridium Difficile Infection, run by Vedanta Biosciences, Inc. at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VE303
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
79 participants
Where
37 sitesin 2 countries
Study dates
8 Feb 2019to 15 Sep 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

37 sites in 2 countries.

37 sites in 2 countries

United States29 sites

  • Anne Arundel Health System Research Insitute

    Annapolis, Maryland, 21401

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Alliance Research Institute

    Canoga Park, California, 91304

  • Advanced Clinical Research-Be Well MD

    Cedar Park, Texas, 78613

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Gastro Florida

    Clearwater, Florida, 33765

  • TruCare Internal Medicine and Infectious Diseases

    DuBois, Pennsylvania, 15801

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104

  • University of Florida

    Gainesville, Florida, 32610

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Infectious Disease Associates of Central Virginia Infectious Disease

    Lynchburg, Virginia, 24501

  • New York University Langone Medical Center

    New York, New York, 10016

  • Phoenix Clinical, LLC

    Phoenix, Arizona, 85014

  • Mayo Clinic, Clinical Studies Unit

    Phoenix, Arizona, 85054

  • Clinrx Research Joseph INC

    Plano, Texas, 75007

  • Mayo Clinic

    Rochester, Minnesota, 55906

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Covenant HealthCare

    Saginaw, Michigan, 48604

  • Seattle Infectious Disease Clinic

    Seattle, Washington, 98101

  • Advanced Clinical Research-Spokane Gastroenterology

    Spokane, Washington, 99202

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Toledo Institute of Clinical Research Inc

    Toledo, Ohio, 43617

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401

  • Ventura Clinical Trials

    Ventura, California, 93003

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada8 sites

  • Foothills Medical Centre - Microbial Health Clinic

    Calgary, Alberta, T2N2T9

  • Q&T Research Chicoutimi

    Chicoutimi, Quebec, G7H7Y8

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N4A6

  • Moncton Hospital

    Moncton, New Brunswick, E1C6Z8

  • CHU de Québec-Université Laval

    Québec, Quebec, G1V 4G2

  • CARe Clinic

    Red Deer, Alberta, T4N6V7

  • Viable Clinical Research

    Scarborough Village, Ontario, M1P2T7

  • Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-

    Trois-Rivières, Quebec, G8Z3R9

Other trials in Canada

About this study

Official title: CONSORTIUM - A Double-Blind Placebo-Controlled Phase 2 Study of VE303 for Prevention of Recurrent Clostridium (Clostridioides) Difficile Infection

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).

Read the detailed 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.

Being tested
VE303, Placebo
Keywords
Clostridium Difficile Infection Recurrence, Clostridium Difficile Infection, Clostridium Difficile, VE303, Consortium, Vedanta, CDI, C. Diff, CDiff, Clostridiodes Difficile Infection Recurrence, Clostridiodes Difficile Infection, Clostridioides Difficile
Medical subject headings
Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VE303Drug

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

  • PlaceboDrug

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

Study groups in NCT03788434
Study groupRoleWhat they receive
VE303 High DoseExperimentalStudy subjects assigned the high dose VE303 arm took 10 capsules (dosage: 8.0 × 10^9 CFU daily) containing VE303 per day for 14 days.
Receives: Drug: VE303
VE303 Low DoseExperimentalStudy 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.
Receives: Drug: VE303
PlaceboPlacebo comparatorStudy subjects assigned to the placebo dose arm took placebo capsules each day for 14 days. The capsules did not contain any VE303.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 8 weeks

Secondary outcomes (2)

  1. VE303 Strains Detected

    Characterize the number of VE303 strains detected in the fecal microbiome at week 24.

    Measured: 24 weeks

  2. 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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2018
  2. Study start8 Feb 2019
  3. Primary completion2 Jun 2021
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03788434
Sponsor's protocol ID
CONSORTIUM (VE303-002)
Acronym
CONSORTIUM
Status last verified
Jun 2023
First submitted
19 Dec 2018
Last updated
3 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37060545

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VE303 in people with Clostridium Difficile Infection Recurrence and Clostridium Difficile Infection, run by Vedanta Biosciences, Inc. at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CDI Recurrence Week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03788434, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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