A clinical trial has begun which will examine whether fecal microbiota transplantation (FMT) by enema is safe and can prevent recurrent Clostridium difficile–associated disease (CDAD), according to a press release from the National Institutes of Health.
CDC/D. Holdeman
CDAD is normally treated with antibiotics such as vancomycin or fidaxomicin; however, it recurs in about 20% of people who receive this treatment. FMT is effective at curing patients with recurring C. diff infections, but long-term safety and a standardized process have yet to be established.
An estimated 162 people aged 18 years or older who have had two or more episodes of CDAD within the previous 6 months will be included in the clinical trial. These patients will be split into two groups: The first will receive an antidiarrheal medication and an FMT delivered by retention enema; the second will receive an antidiarrheal and a placebo colored to look like an active stool sample.
All patients will provide stool and blood samples at designated time points for 1 year after they undergo treatment for CDAD. Stool samples will be examined for gut microbial diversity changes and infectious pathogens; blood samples will be examined for metabolic syndrome markers.
“Clostridium difficile–associated disease, a significant problem in health care facilities, causes an estimated 15,000 deaths in the United States each year. This randomized, controlled trial aims to provide critical data on the efficacy and long-term safety of using fecal microbiota transplants by enema to cure C. diff infections,” NIAID director Anthony S. Fauci, MD, said in the press release.
The full trial page can be found at Clinicaltrials.gov.