Ensayos clínicos

Inclusion Criteria

• ≥ 18 years old
• Medical record documentation of recurrent CDI including a positive C. difficile test within 60 days prior to enrollment and either
  • at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or
  • at least two episodes of severe CDI resulting in hospitalization
• Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics
• A positive stool test for the presence of C. difficile within 60 days prior to enrollment

Exclusion Criteria

• A known history of continued CDI diarrhea despite being on a course of antibiotics prescribed for CDI treatment
• Requires continuous antibiotic therapy for a condition other than CDI
• Previous successful (resolution of CDI diarrhea) fecal transplant for recurrent CDI < 6 months prior to study enrollment
• Previous unsuccessful (recurrent CDI diarrhea was unresolved) fecal transplant
• Previous treatment with RBX2660
• Diagnosis of inflammatory bowel disease (IBD) e.g.
  • Ulcerative colitis
  • Crohn's disease
  • Microscopic colitis
• Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria
• History of chronic diarrhea
• History of celiac disease
• Disease symptoms caused by a confirmed intestinal pathogen other than C. difficile
• Colostomy
• Planned surgery requiring perioperative antibiotics within 3 months of study enrollment
• Life expectancy of < 12 months
• Compromised immune system