Our Services

Science is poised to unlock a new class of therapies that improve health by modulating the vast community of bacteria living within us.  Already, we know that infusing microbiota from a healthy gut can treat the most common hospital-acquired infection in the country, C. difficile.  Early signs suggest that the microbiome may have profound effects on human health. 

We work with a broad spectrum of researchers exploring the microbiome's role, and facilitate collaborations across our network.  If you are interested in proposing a research collaboration, please complete the following Letter of Interest form and email it to us at science@openbiome.orgalong with the CVs of key study personnel.

Before submitting the form, we encourage you to review our Research Collaboration Guide, Quality Metrics, Research FAQs, and Microbiome Primer before submission to inform your proposal. Once you submit the email, our Scientific Advisory Board will review your request and reach out to discuss how we can best support you and your research goals.

We tailor our involvement in investigations on an individual basis, usually blending the following tools and services:  

    • Our universal donor model allows for unprecedented safety and standardization across studies. Each stool donor is able to provide fecal material for many treatments and supply an entire study, enabling researchers to better control for donor variance across patients.

    • We believe that the use of FMT as a treatment for chronic diseases may require long-term maintenance therapy. Providing regular maintenance therapy through endoscopic or enema delivery is impractical. We have developed orally administered capsules that will enable our research partners to deliver long-term maintenance therapy to explore the long-term dynamics of FMT in the management of chronic diseases.

    • OpenBiome’s clinical team is uniquely positioned to support clinical trial design, using aggregated lessons from across our network of hundreds of hospitals and dozens of FMT trials that we have participated in. Early engagement is particularly useful to enable our team of clinicians and scientists to deeply engage in the design process.

    • Stool is classified as an Investigational New Drug (IND) by the FDA. As a result, clinician investigators who wish to perform FMT for diseases other than C. difficile must file an IND application. To facilitate what could otherwise become an arduous process, physicians may reference OpenBiome's Biologics Master File (BB-MF 15543). This file provides federal regulators with comprehensive insight into OpenBiome's processes, and physicians who reference it may use our robust quality and manufacturing protocols rather than developing these documented quality systems internally to support their IND applications.

    • If you are interested in getting involved in microbiome clinical research, but not prepared to develop a full protocol, please fill out this form to tell us about your research interests and practice areas. We'll add you to our research database and reach out as we or our collaborators launch trials that may be relevant to your strengths.

    • The FMT Microbiota Preparation Research Pack provides microbial communities from healthy human donors along with accompanying molecular and clinical characterization data to support research into the human microbiome. It includes 25 aliquots, each containing a 1 ml preparation of concentrated fecal microbiota isolated from a qualified stool donor. These samples can be used both for in-vitro assays and for in-vivo applications in pre-clinical animal models.

    • The Microbiome Metacommunity Standard (MMS) is designed to serve as a cross-platform, cross-center benchmark for users of different sequencing platforms and variable pre-sequencing processing pipelines and to ameliorate the 'batch effect' observed across sequencing runs. MMS users may control not only for sequencing differences within their individual runs, but also among their sequencing runs and the results of any other researchers and centers using MMS.

    • OpenBiome has a strategic collaboration with Finch Therapeutics, a mission-driven biopharmaceutical company that aims to develop novel microbial therapies serving patients with serious and unmet medical needs. In addition to serving as OpenBiome’s contract manufacturer for stool preparations, Finch has significant expertise in bioinformatics, microbiology, molecular biology and drug delivery. By collaborating with Finch, OpenBiome’s clinical research partners may be eligible for funding, pro-bono material, microbial DNA sequencing, advanced molecular characterization techniques and bioinformatics support. If you are interested in the possibility of approaching Finch as a collaborator on your OpenBiome study, please indicate so on your request form.

As we continue to grow, we also continue to prioritize enhancing this set of tools to meet the increasing need for new skills and technology in this space. If you're interested in partnering with OpenBiome and using one of our services, please contact us at science@openbiome.org describing your research goals. 

Reference Documents:

Read about our current collaborations here.