Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (PUNCH CD)

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).