Fecal Microbiology Therapy (FMT) is a therapy for recurrent and severe clostridium difficile infection (C-diff). C-diff is a bacteria that is present in the intestine of some individuals, and its problems can range from a mild illness with diarrhea to a severe life-threatening condition requiring hospitalization. Antibiotics are often able to control the infection, however with this course of treatment there is a very high recurrence rate and it can fail to eliminate the disease condition.
FMT can establish a colony of bacteria that more effectively suppresses C-diff. This process of “fecal donation” placing feces from another person into the intestine of patients with C-diff. To date, FMT has been very effective in patients who are acutely or chronically ill, as well as those who are not improving with traditional antibiotic therapy. In patients who have had 3 or more recurrences, the success rate is typically over 90%.
What are the risks of therapy?
The experience to date has shown FMT to be remarkably safe. As long as the donor is appropriately screened and tested, the risk of transmitting an infection or disease from the donor to the recipient is extremely rare. The risks of FMT are basically those risks related to the procedure required to instill the donated stool (colonoscopy or endoscopy).
Patients that require FMT are often desperately ill, and at times in a life-threatening situation. It is important to note that FMT remains an investigational therapy with uncertainties regarding long-term safety, but importantly offers hope for definitively treating patients with what otherwise can be a medically incurable problem.
How is the stool specimen administered?
The usual method is to administer the stool specimen at the time of a colonoscopy. Ideally, the patient undergoes a standard preparation for colonoscopy. The patient is completely sedated for the procedure while stool is placed in the upper part of the colon.
There are some instances where the more appropriate method is to place the stool specimen from above, endoscopically, with the endoscope placed below the end of the stomach. Patients are sedated for this procedure as well.
Pill forms of the therapy are on the horizon, but not yet available for standard use.
How are donors selected?
When GAP first started doing FMT procedures in 2012, the standard method was to have a family member or friend donate the stool specimen, so long as testing of the blood and feces of this donor demonstrated that the donor did not have a transmissible disease condition, such as hepatitis. This was cumbersome, time-consuming, and expensive, as very often the cost of testing the donor was not covered by insurance companies.
Studies have since demonstrated that frozen stool specimens are equally effective in “curing” C-diff. This is why in 2013, GAP began obtaining specimens from a “frozen stool bank” at Forsyth Medical Center, where they are kept in bulk and available for use when needed. The specimens are provided by OpenBiome, a nonprofit organization housed at the Massachusetts Institute of Technology. OpenBiome has an excellent quality and safety program with very rigorous screening methods. Its donors are extensively screened with a physical examination, review of history, and multiple blood and stool tests to display the ongoing health of the donor. The outcome is that only 5% of stool specimens are actually used.