From Registration to Follow-Up Reporting
This resource will support your journey from becoming an OpenBiome clinical partner, to placing an order, to administering treatment and reporting patient outcomes.
Joining our Clinical Network
Before placing an order, your practice or medical facility must complete a clinical registration form and return it to our clinical outreach team. We must have an account on record for every location to which we ship, including individual facilities within the same health system.
Ordering Material and Shipping
OpenBiome typically processes orders the day after we receive them and ships FMT preparations overnight on dry ice at approximately -20 degrees Celsius.
The following clinical inserts provide instructions on storing, thawing, and administering each FMT preparation formulation.
OpenBiome gathers data on patient outcomes after they receive an FMT. This allows us to continuously monitor the efficacy and safety of our treatments on a per-donor basis, and effectively respond to suspected adverse events in a timely manner.
Adverse Event Reporting
As part of our commitment to enable safe access to accountable, high-quality FMT treatments, all clinical partners that utilize FMT material provided by OpenBiome are required to report adverse events (AEs) to OpenBiome and possibly to the FDA.
Patients can take several simple steps to prepare for their FMT and increase their chances of recovery.