FREQUENTLY ASKED QUESTIONS


    • 1. Email personalbiome@openbiome.org to express your interest, and we will be in touch to discuss your personalized plan.

      2. To move forward, we will schedule a time for you to come our office in Somerville, MA to meet with our medical staff for a consultation and to provide a stool sample to be processed for long-term cryo-preservation.

    • Numerous clinical studies have show that FMT is effective in curing 90% of recurrent C. difficile cases not responsive to standard antibiotic therapies (Kassam et al., 2013) without significant short-term safety risks. You may read more about the evidence for the use of FMT to treat recurrent C. difficile here.

    • There is promising research suggesting that FMT may be an effective therapy for other diseases. OpenBiome supports a number of ongoing studies investigating these new applications for FMT, but there is not yet sufficient evidence to warrant the use of FMT outside of these research settings. Accordingly, the U.S. FDA restricts the use of FMT to the treatment of recurrent C. difficile infections. Patients suffering from other diseases who would like to explore FMT must enroll in a clinical trial or work with their doctor to file an Investigational New Drug (IND) application with the FDA.

    • At this time, this service is only available to individuals who can visit our site to drop off a fresh physical specimen and engage with our team directly. If you live outside the Boston area, but are able to arrange for travel to Somerville for the consultation and deposit, we would be happy to work with you.

    • Your stool will be stored at OpenBiome’s biorepository in Somerville, Massachusetts.

    • Material is viable for at least two years. Microbiological practice suggests that material may be viable for much longer, and we are willing to store material beyond the two year window. We are currently engaged in long-term studies using our cryopreservation methods to determine the viability of these communities after years of storage. By necessity, these studies will take many years to complete, although we will continue to update our storage guidelines as new data becomes available.

    • Each sample will be uniquely identified with a personalized barcode for tracking during management and delivery.

    • The withdraw process is dependent upon the condition you are seeking to treat using your PersonalBiome sample.

      Option A. I have been diagnosed with recurrent C. difficile, and would like to withdraw my banked treatment. What do I do now?

      Contact personalbiome@openbiome.org or call us at (617) 575-2201 to initiate the process. We will arrange for your physician to submit a Withdrawal Form. This form will provide formal documentation of your recurrent C. difficile infection diagnosis, and the medical facility's mailing address to which we will ship your banked stool.

      Note: we will only ship material to the medical facility in which you will receive your fecal transplant, which must be delivered by a qualified clinician.

      Option B. I have been diagnosed with a disease other than C. difficile infection, but for which I believe a PersonalBiome restoration would be beneficial. What do I do now?

      Contact personalbiome@openbiome.org or call us at (617) 575-2201 to let us know about your diagnosis. FDA regulations restrict the use of FMTs – even those derived from autologous material – for the treatment of conditions other than recurrent C. difficile. If there is sufficient evidence for equipoise to proceed with a fecal transplant, your physician will need to submit an Investigational New Drug (IND) application to the FDA proposing treatment of your condition with your personal microbiota sample.

      OpenBiome will require a copy of your physician’s approved IND application and a Withdrawal Form signed by your physician. Once we receive those documents, we will ship your ready-to-use microbiota sample to the medical facility at which you will receive your fecal transplant.

      Note: These policies and procedures may change over time along with the evolving regulatory environment to ensure compliance with FDA guidance.

    • We offer four different formats for the storage of your PersonalBiome microbiota sample: 1) encapsulation, for oral administration; 2) formulation for colonoscopy; 3) formulation for enema; 4) formulation for upper endoscopy. Each formulation has been used with clinical efficacy for the treatment of recurrent C. difficile infection. During your PersonalBiome consultation, our team will work with you to help decide which formulations make the most sense for you.

    • No. We will only ship material to the medical facility in which you will receive your fecal transplant.


    • If you know another individual who would like to bank their stool with OpenBiome, please encourage them contact us at personalbiome@openbiome.org or call us at (617) 575-2201 to initiate the process. They must be able to visit our site in Somerville, Massachusetts for their personal consultation and sample deposit. We cannot accept stool samples on behalf of individuals without their presence and direct consent.


    • We will provide customized pricing depending on the package of services that you select.

Back to PersonalBiome home page