The Clostridioides Difficile Trial of REC-3964

Open to people ages 18-115

• Be 18 years of age or older with Clostridioides difficile infection (CDI) diarrhea associated with a positive stool test for C. difficile toxin[s] prior to randomization. The Clostridioides difficile infection (CDI) episode, severe or otherwise, must have resolved upon receiving vancomycin with a standard duration of treatment. The participant must be randomized within 2 days of completing vancomycin.
• Have high risk for rCDI (a recurrent CDI episode within the last 6 months for which, in the opinion of the treating physician, standard of care treatment is not an option, age ≥65 years, immunocompromised state, or severe CDI on initial presentation) for whom vancomycin would be acceptable therapy. Exceptions may be approved by the Medical Monitor.

• Have an active chronic diarrheal illness from other causes, such as ulcerative colitis or Crohn's disease. Patients with controlled ulcerative colitis or Crohn's disease would be eligible per this Exclusion Criterion.
• Diarrhea cannot be medically controlled by agents that would confound the interpretation of the study results"