Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
The purpose of this study is to see if stool transplant performed by colonoscopy is effective
 at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the
 procedure a stool sample is taken from a healthy donor (usually family member or close
 friend) and transplanted directly into the colon of the patient with C. diff infection. The
 goal of this experimental procedure (called fecal microbiota transplantation) is to replenish
 the good bacteria in the colon that can help prevent C. diff infection from coming back after
 treatment.
Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy
 individual into the gastrointestinal tract of the patient. This has been done in the past for
 recurrent colitis secondary to Clostridium difficile infection (CDI) using different methods
 such as through nasogastric tube, fecal retention enemas, and by colonoscopy. This method of
 treatment was introduced over 50 years ago with high success rates, although it has not been
 until recent that more case studies have been performed, with continued success rates of
 approximately 90%. Studies have found this therapy to be effective with resolution of
 symptoms in most patients, and have found it to be both cost effective and safe.

 The purpose of this study is to use a standardized published protocol for fecal microbiota
 transplantation performed by colonoscopy and record the success rate and outcomes of FMT
 therapy for patients with recurrent CDI at the UMassMemorial Medical Center. In addition, the
 cost of this therapy will be compared to conventional antibiotic treatment. The reduction in
 hospitalizations will also be monitored compared with historical controls.

 The hypothesis of this study is that FMT therapy will show resolution of infection in most
 patients with recurrent CDI, with an overall reduction in cost to the hospital for recurrent
 admissions for Clostridium difficile colitis as compared to historical controls. Historical
 controls will be defined as patients with recurrent positive Clostridium difficile stool
 samples treated in the traditional fashion with antibiotics.
Inclusion Criteria:

 -  Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a
 positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate
 symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier
 episode resolved with or without therapy.

 -  Failed standard therapy with oral metronidazole and/or oral vancomycin

 -  One or more episodes of severe CDI resulting in hospitalization and not responding to
 standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe
 diarrhea, abdominal pain and signs of systemic toxicity

 Exclusion criteria:

 -  Age <16 years old

 -  patients with acute severe colonic dilation at risk for colonic perforation