A workflow for the preparation of frozen stool for fecal microbiota transplantation was validated and implemented in the first nonprofit public stool bank, according to research presented at the American Gastroenterological Association’s James W. Freston Conference.
Mark B. Smith, PhD, and Zain Kassam, MD, MPH, of Massachusetts Institute of Technology, and colleagues reviewed the literature to develop scalable protocols for screening and processing donor stool for fecal microbiota transplantation (FMT). This methodology was validated by leaders in gastroenterology, infectious diseases and related fields during its implementation in OpenBiome.
Mark B. Smith
“OpenBiome was founded by a team of microbiologists, clinicians and public health advocates at MIT and Harvard and is based in Medford, Mass.,” Smith told Healio.com/Gastroenterology. “As the first public stool bank, OpenBiome is like the Red Cross, but for stool.”
Thus far it has provided more than 850 treatments to 91 hospitals in 31 states, and its partner hospitals are within a 4-hour drive of more than 82% of Americans, Smith said. He called the stool bank significant progress toward universal FMT access for patients with Clostridium difficile infection for whom standard antibiotic therapies have failed.
“This could help to mitigate the significant morbidity and mortality associated with what has become the most common hospital-acquired infection, with over 500,000 cases and 14,000 deaths nationally each year,” Smith said.
The OpenBiome workflow screening for potential infectious agents involves a 105-item interview and clinical assessment, a panel of serological and stool-based assays, and continuous requalification and rescreening. Processing entails a method for sterile homogenization and filtering in a class II biosafety cabinet. Characterization is done by high-throughput 16s sequencing and a fluorescent assay.
“For the first time, clinicians will be able to offer FMT for C. difficile patients not responding to standard therapy without the need to develop in-house screening and processing methods,” Smith said. “This will reduce the difficulty of providing this treatment to patients in need and also marks a significant improvement in the safety and rigor of previously presented methods for screening and processing donor stool.” – by Adam Leitenberger
Disclosure: The researchers are affiliated with OpenBiome, but report no relevant financial disclosures.