OpenBiome emerged in 2012 as America’s first non-profit stool bank, founded by a team of scientists and advocates from MIT and Harvard. Its purpose was to address a gap in healthcare by creating a safe supply of material for Fecal Microbiota Transplantation (FMT). This treatment targeted recurrent Clostridioides difficile (C. diff), a debilitating gut infection often resistant to conventional methods. By establishing a centralized system, OpenBiome made this therapeutic option more accessible to hospitals and clinics.
The Mission Behind the Stool Bank
For many patients, standard antibiotic treatments fail to resolve C. diff infections permanently, leading to a frustrating cycle of relapse. This occurs because antibiotics, while targeting C. diff, also disrupt the healthy community of microbes in the gut, leaving the patient vulnerable to reinfection. FMT combats this by restoring a healthy gut ecosystem.
The procedure introduces intestinal microbes from a healthy donor, repopulating the patient’s gut with beneficial bacteria that outcompete C. diff and break the cycle of infection. OpenBiome’s mission was to standardize and scale this process into a readily available treatment.
The Stool Donation Process
The process of becoming a stool donor for OpenBiome was exceptionally rigorous to ensure safety and quality. Potential donors first underwent a comprehensive screening process, starting with an extensive health questionnaire and a clinical interview. This initial step was designed to identify health risks or lifestyle factors that could make a person ineligible to donate.
If a candidate passed the questionnaire, they proceeded to extensive blood and stool testing to screen for a wide range of infectious diseases. These tests were far more detailed than typical health screenings, looking for numerous pathogens to prevent any accidental transmission. This stringent protocol resulted in fewer than 3% of applicants qualifying as donors.
For those accepted into the program, regular and consistent donations were required. Donors would visit an OpenBiome facility to provide samples and complete a short health questionnaire to report any recent changes in their health. This continuous monitoring was part of a health surveillance program to maintain the highest safety standards.
Impact on Treatment and Research
By creating a centralized and scalable system, OpenBiome dramatically expanded patient access to FMT across the United States. It successfully shipped over 72,000 treatments to more than 1,300 hospitals and clinics. This effort turned an experimental therapy into a recognized medical intervention for recurrent C. diff and helped make it a standard of care.
The organization’s work also had a profound effect on scientific research. By providing standardized, safety-screened microbiota preparations, OpenBiome enabled numerous clinical studies. Researchers could access high-quality materials to investigate the role of the gut microbiome in other diseases, including inflammatory bowel disease and autoimmune disorders. This resource helped propel the entire field of microbiome science forward.
The End of an Era and Lasting Legacy
In 2023, OpenBiome ceased providing FMT material for clinical use, marking a significant transition. This change was a direct result of progress in the field it helped build. The U.S. Food and Drug Administration (FDA) approved the first commercially manufactured, regulated microbiome-based therapeutics for recurrent C. diff, including products like Rebyota and Vowst. These approvals signaled a new phase in medicine, with treatments available through a conventional pharmaceutical pathway.
The end of OpenBiome’s distribution service was not a failure but the successful completion of its mission. The organization served as a bridge, proving the therapeutic concept of FMT and meeting a patient need when no other options were available. It demonstrated the viability of microbiome-based treatments, paving the way for the commercial development that followed. OpenBiome has since evolved into a foundation, continuing to support research to advance microbiome science.