Investigational FMT Treatments
Investigational fecal microbiota transplantation (FMT) is a promising therapy for patients with severe or fulminant C. difficile infections. Currently, investigational FMT may only be accessed under approved research protocols.
What is Investigational FMT?
Investigational FMT is a therapy that is not approved by the FDA and must be accessed under an approved research protocol. Currently, you must consult your doctor about whether an investigational FMT is an appropriate option for you.
Questions about Investigational FMT?
Navigating access to investigational medical treatments isn’t always easy. OpenBiome is here to help. If you’re having trouble finding answers or simply prefer to talk with someone one-on-one, reach out to us at the provided email address or phone number.
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Introduction to Investigational FMT
Within all of us is a community of bacteria known as the microbiome. These bacteria help our bodies to digest food, fight infections, and perform other key functions that keep us healthy.
Investigational fecal microbiota transplantation (FMT) is a medical procedure that transfers the microbial community from a screened, healthy donor into a patient’s gut to help treat their illness. This procedure is typically performed through a colonoscopy.
Using Investigational FMT to Treat C. difficile Infections
Most patients with C. difficile are infected after receiving antibiotics for an unrelated illness.
Although antibiotics are powerful and life-saving medications, they may also disrupt the healthy bacteria that normally prevents the growth of infectious microbes like C. difficile.
Some studies suggest that investigational FMT may repopulate a patient’s damaged microbiome with a diverse community of microorganisms. This community may limit C. difficile's ability to find the space and nutrients to grow.
Am I Eligible for an Investigational FMT?
Currently, investigational FMT may only be accessed under an Investigational New Drug (IND) application. Most commonly, this involves enrollment in an approved clinical trial. Each trial is unique in terms of enrollment criteria. To locate relevant trials near you, please visit the National Clinical Trials Registry.
Next Steps for Receiving an Investigational FMT
Investigational FMT may only be accessed under an Investigational New Drug application. This is most commonly done through clinical trials but may also be accomplished through expanded-access or compassionate-use programs. Please consult your care team to determine what option makes most sense for you.
Additional Resources About Investigational FMT
We’ve curated the following resources on investigational FMT and C. difficile to provide a more comprehensive understanding of what’s been discussed above. This information is for physicians and patients alike.
Selection from OpenBiome’s White Paper Collection
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