Novel treatment protocol targets the deadliest cases of C. difficile infection

A new study from the University of Minnesota Medical School has demonstrated that fecal microbiota transplantation (FMT) can rapidly reverse systemic inflammation and improve survival in patients with fulminant Clostridioides difficile (C. difficile) infection—a life-threatening condition characterized by a sepsis-like state. The findings are published in Clinical Gastroenterology and Hepatology.

C. difficile infection is the most common cause of health care-acquired diarrheal illnesses. Most of the mortality, estimated at 15,000 people annually in the United States alone, is associated with the severe and fulminant forms of the disease. C. difficile is listed as one of the most urgent infectious disease threats by the Centers for Disease Control and Prevention. The infection occurs in people with disrupted microbial communities in the gut, most commonly by antibiotic medications.

In this study, investigators implemented a standardized FMT protocol developed at the University of Minnesota specifically for critically ill patients who were deteriorating despite intensive antibiotic therapies and were often too unstable for surgery. Among 18 patients treated, FMT was associated with rapid declines in inflammatory markers and achieved a 30-day survival rate of 78%.

“There is an important caveat to our findings—the window for the FMT intervention is very narrow because these patients are generally extremely sick,” said Alexander Khoruts, MD, professor at the University of Minnesota Medical School, director of the UMN Microbiota Therapeutics Program and a gastroenterologist with M Health Fairview. “Therefore, the FMT formulation needs to be easily accessible. We are in a unique position at the university because we have a facility in our institution where our FMT products are manufactured in accordance with pharmaceutical standards, and treatment units are always on hand in our cryobank.”

Importantly, the findings also suggest an entirely novel mechanism by which FMT can modulate systemic inflammation in severe C. difficile infection. This is a topic of ongoing research. The team is also currently working to make this FMT treatment option more widely available to patients across the United States.