Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 6/27/2018 |
| Start Date: | January 16, 2014 |
| End Date: | January 16, 2023 |
| Contact: | Anne Foley |
| Email: | IBDClinicalTrials@umassmed.edu |
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.
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.
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
We found this trial at
1
site
Worcester, Massachusetts 01605
Principal Investigator: Randall Pellish, MD
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