Media Backgrounder C. Diff Infection and Fecal Microbiota Transplantation

Clostridium Difficile Infection

Clostridium difficile (C difficile or C. diff) is a bacterium found in the environment and colon.  It is the most common cause of infectious diarrhea in hospitals and long-term care homes.  C. difficile infection should be suspected if a patient has watery diarrhea for two days or more, abdominal cramping or pain, fever, nausea and loss of appetite.  It is diagnosed with a stool sample.

Risk factors for acquiring C. diff infection include:  recent (<3 months) antibiotic use, history of C. diff infection, recent hospitalization or placement in a nursing home or long-term care facility, age greater than 65 years, gastric acid suppression (use of proton pump inhibitors or H₂-blocker), comorbid conditions (cancer, chronic kidney disease), or gastrointestinal surgery or procedure. 

C. diff infection may lead to serious complications including sepsis and/or bowel perforation.  Management of C. diff infection depends on the severity of the symptoms.  Mild cases may be treated in the outpatient setting, but severe cases are better managed in the hospital setting.

Reference:

• Bagdasarian N, Rao K, Malani PN. Diagnosis and treatment of Clostridium difficile in adults: a systematic review.  JAMA 2015;313(4):398-408.

Fecal Microbiota Transplantation

Fecal microbiota transplantation (FMT) or fecal (stool) transplant is a treatment for recurrent Clostridium difficile (C. difficile).  C. difficile is bacterial infection that causes diarrhea.  At this time, FMT treatment is still considered investigational by the FDA as draft guidance is underway.  Despite its lack of FDA approval, it is considered to be a highly effective and acceptable treatment for recurrent C. difficile, which can be a serious condition.

This treatment works on the premise that healthy intestinal bacteria, when transferred to a patient with an unhealthy balance of bad to good bacteria, can create healthy changes in the patient's intestinal bacteria and improve his or her condition.

How is FMT performed?

FMT involves the administration of donor feces from a healthy individual into a patient with recurrent C. difficile.  Donors are carefully screened for recent antibiotic use, recent hospitalization, various medical disorders, viral infections (HIV, Hepatitis A, B, C), infectious causes of diarrhea, and syphilis. 

Donor stool is liquefied and transplanted into the infected patient.  Transplantation can be accomplished in a variety of ways.   Although there is no consensus on the best approach for transplantation, the colonoscopic approach tends to be preferred.   During the colonoscopy, the liquefied stool is infused into the colon.  

Who is eligible for FMT?

• Patients who have persistent C. difficile infection despite at least three courses of standard therapy.
• Patients with at least three documented episodes of C. difficile infection despite adequate treatment and response with appropriate antibiotics.
• Patients with C. difficile infection and a lack of response to appropriate antibiotics. 

How do patients prepare for FMT?

Patients will continue on antibiotic therapy for C. difficile until the day prior to the procedure.  A bowel preparation is given in split dose or dosed the evening prior to the procedure, similar to preparation for a standard colonoscopy. 

Is FMT safe?

It appears to be safe as long as all donors are screened appropriately for known potential blood and stool borne infections.  The long-term risks for the procedure are unknown.

How effective is FMT?

Approximately 92% of patients with recurrent C. difficile are cured (range 81-100%) based on a recent study published in Gastrointestinal Endoscopy¹.

Reference:

• Brandt LJ, Aroniadis OC. An overview of fecal microbiota transplantation: techniques, indications, and outcomes.  GIE 2013;78(2):240-249.

Source:  American Society for Gastrointestinal Endoscopy, June 2016