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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Clostridium Difficile Infection
  • Age: Between 18 - 150 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are 18 years of age or older
    2. Subjects who are able and willing to provide written informed consent
    3. Subjects with a qualifying episode of CDI as per the protocol
    4. Subjects of child bearing potential must agree to use effective acceptable form of birth control
    5. Subjects who are able to receive the first dose of study drug on the last planned day of administration of SOC antibiotics for a qualifying episode of CDI, or no later than 1 day after completion of antibiotic dosing.
    6. Subjects who able and willing to follow study procedures
    7. Subjects who recovered from any complications of severe or fulminant CDI and clinically stable by the time of randomization.

You may not be eligible for this study if the following are true:

    1. Subjects who have history of diarrhea
    2. Subjects who have Known or suspected toxic megacolon and/or known small bowel ileus at the time of randomization.
    3. Subjects who hase contraindication to oral/enteral therapy
    4. Subjects who have presence of white blood cell (WBC) count > 15 × 109 cells/L, or body temperature > 38.5 °C at the time of randomization.
    5. Subjects who have had 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. Subjects use of drugs that alter gut motility
    7. Planned administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization.
    8. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization.
    9. Subjects with compromised immune system
    10. Current or immediate potential for mechanical ventilation or vasopressors for hemodynamic support.
    11. Life expectancy of < 3 months
    12. Subjects who had major gastrointestinal surgery
    13. Subjects with anticipated admissions to an intensive care unit.
    14. Subjects who are pregnant or breastfeeding
    15. Subjects with known hypersensitivity/allergy/intolerance to any ingredient in the VE303 study formulation (sucrose, histidine, yeast extract, cysteine, metabisulfite, and micro-crystalline cellulose)
    16. Subjects who have history of confirmed celiac disease, inflammatory bowel disease, short gut, gastrointestinal tract fistulas, or ischemia.
    17. Subjets who are clinically significant medical or surgical condition not mentioned in the above criteria that, in the Investigator’s opinion, could interfere with the administration of study drug, interpretation of study safety or efficacy data, or compromise the safety or well- being of the subject.



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