Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea
Condition: Recurrent Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Recurrence; Diarrhea
Intervention: RBX2660 (microbiota suspension)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile; C diff; Microbiota Restoration Therapy; MRT; microbiota suspension; CDI; CDAD; Fecal transplant; Fecal Microbiota Transplant; FMT; Diarrhea; Fecal bacteriotherapy

Summary:

      This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as
      a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the
      primary symptom of recurrent Clostridium difficile infection. All eligible subjects will
      receive RBX2660.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years

          -  Medical record documentation of CDAD either: a) at least two recurrences after a
             primary episode and have completed at least two rounds of standard-of-care oral
             antibiotic therapy or b) have had at least two episodes of severe CDAD resulting in
             hospitalization.

          -  Willing and able to have an enema(s).

          -  Already taking or will start a course of oral antibiotics for CDAD symptoms for 10-14
             days, including at least seven days of oral vancomycin.

          -  Willing and able to complete the required subject diary.

        Exclusion Criteria:

          -  Continued (uncontrolled) CDAD after completing a 10-14 day course of oral antibiotics.

          -  Requires antibiotic therapy for a condition other than CDAD.

          -  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.

          -  History of cirrhosis of the liver or ascites.

          -  Disease symptoms caused by a confirmed intestinal pathogen other than Clostridium
             difficile.

          -  Has a colostomy.

          -  Intraabdominal surgery within the last 60 days.

          -  Evidence of active, severe colitis.

          -  History of short gut syndrome or motility disorders.

          -  Requires the regular use of medications that affect bowel motility (e.g.,
             metoclopramide, narcotics, loperamide).

          -  Planned therapy in the next 3 months that may cause diarrhea (e.g., chemotherapy).

          -  Planned surgery requiring perioperative antibiotics within 6 months of study
             enrollment.

          -  Life expectancy of < 12 months.

          -  Compromised immune system, e.g., HIV infection (any CD4 count); AIDS-defining
             diagnosis or CD4 <200/mm3; inherited/primary immune disorders; immunodeficient or
             immunosuppressed due to a medical condition or medication; current or recent (< 90
             days) treatment with chemotherapy; or current or recent (< 90 days) treatment with
             immunosuppressant medications.

          -  Taking steroids (≥ 20 mg a day) or is expected to be on steroids for more than 30 days
             after enrollment.

          -  Neutropenia (white blood cell count <1000 cells/µL).