Office of Research & Development |
|
VA researchers at Minneapolis VA Health Care System will examine the home use of fecal transplants to combat recurrent C. difficle infection. (Illustration: Centers for Disease Control and Prevention)
VA researchers at the Minneapolis VA Health Care System are beginning a new clinical trial to assess the effectiveness of home use of fecal microbiota therapy (FMT) to prevent recurrence of Clostridium difficile (C. difficile) infections. The study is called Microbiota or Placebo after Antimicrobial Therapy for Recurrent C. difficile at Home (MATCH).
MATCH (CSP #2004) will assess the effectiveness of FMT delivered via an oral capsule, rather than by colonoscopy. While fecal transplants, given after antibiotic therapy, have shown promise in the treatment of recurrent C. difficile infection in smaller studies, there is a lack of larger clinical trials to establish efficacy. Currently, the FDA requires an investigational new drug application for any research using FMT.
The study, sponsored by the VA Cooperative Studies Program, opened for recruitment in November 2018. Eligibility requirements for Veterans include having had one or more episodes of recurrent C. difficile infection; resolution or improvement of symptoms from the most recent C. difficile infection; and enrollment within 2 to 14 days after completion of antibiotic therapy, or 30 days after onset of C. difficile. Eligible Veterans may live anywhere in the United States, and will be enrolled at their place of residence. All follow-up will be conducted by study coordinators via telephone.
While C. difficile is a common hospital-acquired infection, more than 90 percent of patients recover after a standard course of antibiotic therapy. However, recurrence is common. After the first episode of infection, recurrence rates are between 15–30 percent. That increases to 40–50 percent after the second and subsequent episodes of C. difficile.
