Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
Condition: Clostridium Difficile Infection (CDI)
MeSH terms: Infections; Communicable Diseases; Clostridium Infections
Intervention: RBX2660; Placebo; Open label RBX2660 (only for confirmed CDI recurrence)
Intervention description: RBX2660 is a rectally administered microbiota suspension; Placebo is normal saline solution administered rectally; RBX2660 administered as a second treatment after confirmed CDI recurrence following the initial dose of placebo or RBX2660
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: C Difficile Colitis; Clostridium Difficile; CDI; C.Difficile Diarrhea; Fecal Transplant; Fecal Microbiota Transplant (FMT); Microbiota Restoration Therapy; Diarrhea; FMT; Microbial Suspension

Summary:

      This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3
      study of a microbiota suspension of intestinal microbes. Patients who have had at least one
      recurrence after a primary episode and have completed at least one round of standard-of-care
      oral antibiotic therapy or have had at least two episodes of severe Clostridioides difficile
      infection (CDI) resulting in hospitalization within the last year may be eligible for the
      study. Subjects who are deemed failures following the blinded treatment per the pre-specified
      treatment failure definition may elect to receive an unblinded dose of RBX2660.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ≥ 18 years old.

          2. Medical record documentation of recurrent CDI per the study definition, that includes
             either: a) at least one recurrence after a primary episode and has completed at least
             one round of standard-of-care oral antibiotic therapy or b) has had at least two
             episodes of severe CDI resulting in hospitalization within the last year.

          3. A positive stool test for the presence of toxigenic C. difficile within 30 days prior
             to or on the date of enrollment.

          4. Is currently taking or was just prescribed antibiotics to control CDI related diarrhea
             at the time of enrollment.

        [Note: Subject's CDI diarrhea must be controlled (<3 unformed/loose stools/day) while
        taking this course of antibiotics]

        Exclusion Criteria:

          1. Currently has continued CDI diarrhea despite being on antibiotics prescribed for CDI
             treatment.

          2. Previous fecal transplant

          3. History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's
             disease, or microscopic colitis.

          4. Diagnosis of irritable bowel syndrome (IBS) as determined by Rome III criteria.

          5. Compromised immune system (e.g. immunosuppressed due to a medical condition or
             medication; current or recent (< 90 days) treatment with chemotherapy)

          6. An absolute neutrophil count of <1000 cells/µL during screening.

          7. Pregnant, breastfeeding, or intends to become pregnant during study participation.