18 Years and up
Accepting Healthy Volunteers?
- ≥ 18 years old.
- Medical record documentation of recurrent CDI including a positive C. difficile test
within 60 days prior to enrollment and either: a) at least two recurrences after a
primary episode and has completed at least two rounds of standard-of-care oral
antibiotic therapy or b) has had at least two episodes of severe CDI resulting in
- 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
- 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, or 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.
- Planned surgery requiring perioperative antibiotics within 3 months of study
- Life expectancy of < 12 months.
- Compromised immune system