Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
This is the first prospective, multi-center, double-blinded, randomized controlled study of a
 microbiota suspension derived from intestinal microbes. Patients who have had at least two
 recurrences of C. difficile infection (CDI) after a primary episode and have completed at
 least two rounds of standard-of-care oral antibiotic therapy or have had at least two
 episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients
 whose CDI returns in less than 8 weeks after the last assigned study treatment may be
 eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
This is the first prospective, multi-center, double-blinded, randomized controlled study of a
 microbiota suspension derived from intestinal microbes. The primary assessments for this
 study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via
 assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with
 additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least
 two recurrences of C. difficile infection (CDI) after a primary episode and have completed at
 least two rounds of standard-of-care oral antibiotic therapy or have had at least two
 episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients
 whose CDI returns in less than 8 weeks after the last assigned study treatment may be
 eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Inclusion Criteria:

 -  ≥ 18 years

 -  Medical record documentation of recurrent CDI 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 C. difficile diarrhea while taking on a course of
 antibiotics prescribed for CDI treatment.

 -  Requires antibiotic therapy for a condition other than recurrent CDI.

 -  Previous fecal transplant prior to study enrollment.

 -  History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's
 disease, or microscopic colitis.

 -  History of irritable bowel syndrome (IBS).

 -  History of chronic diarrhea.

 -  History of celiac disease.

 -  Colostomy.

 -  Planned surgery requiring perioperative antibiotics within 6 months of study
 enrollment.

 -  Life expectancy of < 12 months.

 -  Compromised immune system.