Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
Condition: Clostridium Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: RBX2660; Standard of Care Antibiotics
Intervention description: suspension of intestinal microbes; Standard of Care Antibiotics
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; C diff; CDI; CDAD; Fecal transplant; Fecal Microbiota transplant; diarrhea; FMT; microbiota restoration therapy; microbiota suspension; fecal bacteriotherapy; C diff diarrhea

Summary:

      This study will evaluate efficacy and safety information about RBX2660 for the treatment of
      recurrent Clostridium difficile infection (CDI), and will compare the efficacy of one
      treatment with RBX2660 versus antibiotic-treated historical controls. Enrolled subjects will
      receive one treatment consisting of two doses of RBX2660 (microbiota suspension).
    

Eligibility criteria:

        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