Standardized FMT Protocol May Improve Survival in Severe C. difficile Infection

difficile) infection is a leading cause of health care-acquired diarrhea, and the fulminant form carries high mortality. Many critically ill patients deteriorate despite intensive antibiotics and are often too unstable for surgery, creating an urgent therapeutic gap. Rapid control of systemic inflammation in this sepsis-like state is a key clinical need. New findings demonstrate that a standardized fecal microbiota transplantation approach may quickly reduce inflammation and improve short-term survival in these cases.

At the University of Minnesota Medical School, investigators implemented a standardized fecal microbiota transplantation (FMT) protocol for critically ill patients with fulminant C. difficile infection who were deteriorating despite intensive antibiotic therapies and often too unstable for surgery. The study, published in Clinical Gastroenterology and Hepatology, evaluated whether FMT could reverse the systemic inflammatory response characteristic of these cases. The protocol was developed specifically for use in patients in whom conventional options were failing.

Among 18 patients treated under the protocol, FMT was associated with rapid declines in inflammatory markers and a 30-day survival rate of 78%. The authors note that C. difficile is the most common cause of health care–acquired diarrheal illness and that most of the estimated 15,000 annual U.S. deaths occur in severe and fulminant disease. The infection arises in people with disrupted gut microbial communities, most commonly after antibiotic exposure.

The findings also suggest a novel mechanism by which FMT can modulate systemic inflammation in severe C. difficile infection, which the team identifies as an area of ongoing research. Investigators are working to make this FMT treatment option more widely available across the United States. The work was provided by the University of Minnesota Medical School.

"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," said Dr. Khoruts. 

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