Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

This is a prospective, multicenter, open-label study assessing the efficacy and safety of RBX2660 as an adjunct to antibiotics for the treatment of recurrent CDI. Efficacy of RBX2660, measured by the recurrence-free rate of CDI diarrhea without the need for retreatment with C. difficile anti-infective therapy or fecal transplant through 56 days after completion of study treatment with RBX2660, will be evaluated by comparing the recurrence-free rate observed in the study population to the recurrence-free rate identified from antibiotic-treated historical controls.

Patients who have had either a) at least two recurrences after a primary episode (i.e., at least three episodes) and have completed at least two rounds of standard-of-care oral antibiotics or b) have had at least two episodes of severe CDI resulting in hospitalization may be eligible to participate in the study. Study visits are 1- and 8-weeks after treatment with additional follow-up assessments at 3,6,12, and 24 months post treatment.

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: 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 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, 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.
• Colostomy.
• Planned surgery requiring perioperative antibiotics within 3 months of study enrollment.
• Life expectancy of < 12 months.
• Compromised immune system