Frequently Asked Questions


    • No. To ensure safe and appropriate use and to comply with FDA regulations governing investigational therapies, we only provide material to doctors for administration in a clinical setting. To find a doctor near you who already performs FMT, check this map. In addition to working with existing FMT practitioners, we're happy to help new practitioners provide FMT. Any gastroenterologist should be capable of providing FMT given appropriately screened and processed material, which we can provide. If your doctor does not yet offer FMT, we are willing to speak with him or her about whether we can facilitate FMT in his or her practice.

    • Only in the setting of a clinical study. The FDA regulates the use of fecal microbiota for FMT as an investigational drug. The FDA has decided to practice enforcement discretion for C. difficile patients, allowing clinicians to treat these patients without completing an Investigational New Drug application (IND). Clinicians must file an IND in order to perform FMT for any other purpose.

      OpenBiome currently working with investigators to run more than 30 clinical trials taking place both within the United States and elsewhere around the world. These studies are seeking to treat a wide range of indications including recurrent Clostridium difficile infections, inflammatory bowel disease, pouchitis, food allergies, multiple sclerosis, and depression. Our clinical trials portfolio accounts for 36% of all FMT trials in the United States as well as the first and only clinical trial taking place on the African continent. You can check this map to find a clinical trial to enroll in. You can also go to clinicaltrials.gov for other active studies.

      Generally, however, FMT is not available for patients who do not have recurrent C. difficile, and we are not currently able to support these emerging applications for FMT outside of research settings.

    • No. Clinical studies have shown that fecal transplants from anonymous, unrelated donors are as effective as fecal transplants from blood relatives or “known” donors. Enforcement discretion to enable the treatment of C. difficile patients applies for both universal and "known" donors.

    • We work with clinicians internationally on a case-by-case basis. The use of fecal microbiota for FMT is regulated differently in each country, and shipping our material internationally is also subject to regulation. Given this added regulatory complexity of international collaboration, it may be easier to work through your existing domestic health care network rather than with us. However, if your medical provider can verify the regulatory environment is conducive to working with us, we are more than happy to help. Please note that OpenBiome is unable to provide FMT material to European Union member state countries.

    • The costs of administration will vary by hospital and by mode of administration (which may include colonoscopy, enema, nasogastric tube, or capsules). Many components of FMT administration may be covered under your health insurance plan.

      We provide FMT Upper Delivery and FMT Lower Delivery microbiota preparations for $1595 per treatment. We also offer FMT capsules for $1950 per dose. The cost of comparable screening for your own donor can exceed $3500 out-of-pocket. You should talk to your health care provider to see how insurance coverage may affect your costs for these options.

    • We are a 501(c)(3) non-profit organization. Our operating costs are funded primarily through user fees collected from hospitals, but we fund our research efforts and provide pro bono treatments for patients in need of financial support through private donations. If you would like to help us expand access to FMT, we would be grateful to receive your tax-deductible gift here.

    • Our fecal microbiota preparations are collected from healthy donors who have passed a battery of health screenings, including a 200-point clinical questionnaire and more than 2 dozen blood and stool screens. Our donors are also continuously monitored, and rescreened again at the end of their donation period before their material is released for treatment.

    • Stool from rigorously screened donors is processed into FMT treatments in a specialized, good manufacturing practice (GMP)-certified facility. Within our laboratories, HEPA filters and positively pressured airflow maintain a sterile environment. Our technicians follow a carefully validated set of standard operating procedures to ensure consistent quality production. First, stool is handled and examined for any signs of pathology under a Class II Biology Safety Cabinet that is UV-sterilized and cleaned with a sporicidal agent. Stool is then mixed with a glycerol buffer, filtered for particulates, and stored in bottles with tamper evident bands. To preserve the therapeutic potential of stool, FMT units are stored at -80 degrees Celsius and transported to clinical partners on dry ice with temperature verification.

    • When a friend of ours fell ill with C. difficile, it took him 18 frustrating months to receive an FMT and recover. At that time, few doctors offered FMT because of the logistical barriers of screening and processing material within busy and tightly regulated hospitals. We started OpenBiome so that other patients could avoid our friend's painful experience. By providing clinicians with carefully screened, ready-to-use material, we hope more doctors will be able to offer FMT, reducing the need for patients to wait or travel to receive what should be an inexpensive and simple treatment.