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Fecal Microbiota Transplantation (FMT), Bacteriotherapy, Live Biotherapeutic Products
Fecal Microbiota Transplant (FMT)
- What is FMT?
FMT refers to the act of giving stool collected from a healthy person into the intestinal tract of a patient. The purpose of the procedure is to replace the unhealthy microbiota of a patient with that of a heathy donor.
- What is the microbiota?
'Microbiota' describes the community of microbes (bacteria, virus, and fungus) that live in unity with us. In this case, within the intestinal tract of a patient.
- Are all microbes harmful?
No. In fact, most microbes are important in keeping us healthy. Many microbes can help digest nutrients, make vitamins, break down hormones, and help our immune system by keeping away harmful microbes.
- What is Bacteriotherapy?
Bacteriotherapy is the term used when we use these microbes or their products to treat an illness. Probiotics and FMT are examples of bacteriotherapy.
- What are probiotics?
What are probiotics? Probiotics are microbes that have health benefits for the host. Most probiotics available to purchase come from food sources such as cultured or fermented foods and are ingested in capsule or powder form.
- What is the difference between probiotics and FMT?
Probiotic products include one or a few types of helpful organisms and are usually taken by mouth in the form of food (like yogurt), a pill, or powder. FMT is when the entire population of microbes (after checking for the known harmful ones) is given; it can be ingested in capsules, rectally by enema or given during colonoscopy.
- Who may be a candidate for FMT?
Currently, FMT is only used to treat patients with recurrent Clostridioides difficile infection (CDI).This bacteria is a very common bacteria. However, when it is given the chance to overgrow in the gut (usually in the setting of antibiotics that kill the beneficial microbes), it can cause diarrhea and colitis (inflammation of the colon). When patients have this infection over and over it is called “recurrent.”
- How does FMT cure recurrent C. difficile infection?
FMT works by re-populating the natural balance and diversity of the intestinal microbiota via donor stool. The donated stool contains the protective microbiota that keeps C. difficile at bay, and rebuilds a stable environment in the large intestine.
- Is FMT FDA-approved?
As of 2021, the Food and Drug Administration (FDA) only approves FMT for patients with recurrent C. diff. It is considered an experimental treatment for all other reasons. Use of FMT for any other illness should only be done in a research study.
- What are the risks of FMT?
Overall, FMT is considered safe with mild side effects (diarrhea and abdominal discomfort that goes away without medical intervention) occurring in up to 28% of patients. Serious complications including becoming infected with a harmful microbe, is very rare.
- Where does the FMT material come from and how much does it cost?
When FMT first started, donor stool came from screened healthy family members or friends of the patient who needed the transplant. This is still possible, but can cost >$500 to complete the tests needed to find a healthy donor (blood tests and stool tests). It may not be covered by insurance companies. Now, we can get frozen specimens from pre-screened healthy donors stool banks. The cost for FMT is usually between $500-$1,500 depending on how it’s given, insurance coverage, and where the stool comes from.
- What are Live Biotherapeutic Products (LBPs)?
LBPs are FDA-approved products containing live organisms like bacteria and bacterial spores. They are used to restore the normal bacterial flora in our intestines.
- What is the difference between traditional FMT and LBPs?
Traditional FMT is not an FDA-approved product. It is allowed for discretionary use by providers for recurrent C. difficile Infection. LBPs are FDA-approved products.
- Is LBP indicated for diseases other than recurrent C. difficile Infection?
No. The current FDA indication is for recurrent C. difficile Infection.
- What LBPs are currently available for recurrent C. difficile Infection?
Live-jslm (Rebyota), was approved in November 2022, to be given as rectal enema and live—brpk (Vowst, fecal microbiota spores) was approved in April 2023, in oral capsule formulations are the two currently available products.
- What is IMT?
IMT stands for Intestinal Microbiota Transplantation, which describes the transplantation of microbiota-derived from the intestine. It is sometimes used synonymously with FMT.
- How can I find a doctor who performs FMT?
Check with your primary care provider, local medical center, or gastroenterologist who can refer you to a local physician performing FMT. There are also many private, online websites that maintain registries of providers.
Author(s) and Publication Date(s)
Ronald Hsu, MD, FACG, University of California, Davis School of Medicine, Davis, CA, and Neil Stollman MD, FACG, University of California, San Francisco School of Medicine, San Francisco, CA – Published July 2016.
Jared Magee, DO, MPH, National Capital Consortium, Walter Reed National Military Medical Center, Bethesda, MD – Updated July 2021.
Daniela Jodorkovsky, MD, Columbia University Medical Center, New York, NY – Updated June 2022.
Ronald Hsu, MD, FACG, University of California, Davis School of Medicine, Davis, CA – Updated July 2024.