RESTORATIVE303 STUDY for Prevention of Recurrent Clostidioides Difficile Infection

  • Study Sponsor and Protocol Number: 
    Vedanta Biosciences, Inc / VE303-003
  • Specialty:
    Infectious Disease
  • Type:
    Investigational Product (oral)
  • Inclusion:
    > 12 years of age with a qualifying episode of C.Diff infection
    Stool sample collected for study-related testing before or no later than 72 hours after initiation of standard-of-care antibiotic therapy with positive EIA for toxin A/B and GCD
    Able to receive the first dose of study drug on the last planned day of standard-of-care antibiotic dosing
    Able and willing to follow study assessments (eg, able to swallow oral capsules, comply with study visits and procedure, provide blood and stool samples, complete questionnaires)
  • Exclusion:
    History of chronic diarrhea within 3 months prior that is not related to C.Diff
    History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, gastrointestinal (GI) tract fistulas or a recent episode of intestinal ischemia or ischemic colitis