Yes, registered physicians may continue placing orders for investigational FMT preparations to treat patients with C. difficile infections not responsive to standard therapies.  

REBYOTA™, the first fecal microbiota product approved by the U.S. Food and Drug Administration (FDA), will provide a much-needed treatment option for patients. REBYOTA is approved for the prevention of recurrence of C. difficile infection (CDI) in individuals 18 years of age and older, and is for use after an individual has completed antibiotic treatment for recurrent CDI.  

OpenBiome operates under FDA oversight and maintains an Investigational New Drug (IND) Application that is kept current in accordance with regulations and guidelines.  

Investigational FMT material—manufactured by UMN and distributed by OpenBiome under an IND—has been manufactured in accordance with current Good Manufacturing Practice (cGMP) regulations. Stool donors undergo regular and rigorous screening for infectious agents and health risks to patients including SARS-CoV-2 and Monkeypox. Donated stool is directly tested for enteric pathogens and multi drug-resistant organisms including VRE, MRSA, ESBL, and CRE. More comprehensive information can be found in Investigator’s Brochures that are available upon request.