Fecal Microbiota Transplant
Fecal transplantation is a procedure to collect feces, also called stool or poop, from a healthy donor and introduce them into a patient’s gastrointestinal tract. The procedure can control an infection called Clostridium difficile, or C. diff, by adding healthy bacteria into the recipient’s intestines. FMT can be performed in children and adults.
Research shows that fecal transplant can restore healthy bacteria in the lower intestine, which can help control C. diff and keep it from coming back. In some cases, FMT can be more effective than antibiotics for keeping C. diff in check.
What is C. diff?
A healthy digestive tract has thousands of bacteria. In most cases, these bacteria are helpful to digestion, or are harmless. However, treatment with antibiotics, which may be required for certain conditions, can kill off many of the good bacteria in the colon. This can allow the bad bacteria, called Clostridium difficile (C. diff) to take over.
C. diff can cause fever, diarrhea and cramping. People can get C. diff after being treated with antibiotics for an infection. In people over age 65 and in those with chronic illness, C. diff infection can be severe — even fatal.
How does a fecal transplant work?
A fecal transplant puts stool full of healthy bacteria into your colon. When you have enough good bacteria in your gut, the bad bacteria that cause disease are held in check. Antibiotics can wipe out the bacteria that make you sick. But they may also clear out the bacteria that keep your body healthy. Without that balance, the bad bacteria can take over. They produce toxins that make you sick with diarrhea and colitis.
A fecal transplant can restore your gut’s healthy bacteria balance. This will help you fight the infection and feel better quickly. It may also help your body resist C. diff in the future.
Is FMT approved by the FDA?
The medical community is actively engaged in exploring the potential uses of Fecal Microbiota for Transplantation, or FMT. Although FMT is not approved by the FDA for any use, the agency plays a critical role in supporting product development while assessing the risks and benefits to patients of unapproved therapies. The agency also works to strike a balance between assuring patient safety and facilitating access to unapproved treatments for unmet medical needs.
For example, the FDA has issued guidance stating that it intends to exercise enforcement discretion, under limited conditions, regarding the investigational new drug requirements for FMT used to treat Clostridium difficile infection unresponsive to standard therapies,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research.
“While we support this area of scientific discovery, it’s important to note that FMT does not come without risk. We’ve become aware of infections with multi-drug resistant organisms after patients received investigational FMT, including one patient death. We therefore want to alert all health care professionals who administer FMT about this potential serious risk so they can inform their patients. Today’s safety communication underscores the importance of why new therapies are thoroughly studied to ensure the benefits of taking them outweigh the risks to patients, and we will continue to aggressively monitor clinical trials to ensure patients are protected when safety concerns arise.