Fecal microbiota live – jslm (Rebyota™/RBL) for management of recurrent Clostridioides difficile infection

Abstract

There is an unmet need for effective treatments of Clostridioides difficile infection, an emerging health crisis in the United States. The management of C. difficile infection should include treatment of active infection and a strategy to prevent recurrence. Current gold standard therapy includes oral antibiotics which predispose patients to gut dysbiosis and increase the risk of recurrent infection. Addressing dysbiosis via fecal microbiota transplantation is an active and promising area of research, but studies have lacked standardization which makes outcome and safety data difficult to interpret. Rebyota™, formerly known as RBX2660, is a live biotherapeutic product designed using a standardized protocol and manufacturing process that has been shown to be effective for preventing recurrent C. difficile infection.

Plain language summary

Clostridioides difficile infection is becoming more common in the USA and causes profuse diarrhea that can be deadly. Treatment with antibiotics causes dysregulation of the bacteria in the gut putting patients at a higher risk of reinfection. Fecal microbiota live – jslm is a new therapy approved by the US FDA that uses stool from healthy donors to return gut bacteria levels to normal after treatment for a C. diff infection.

Article highlights

• Treatment of Clostridioides difficile infection with antibiotics followed by fecal microbiota live – jslm (RBL/Rebyota™) is more effective than antibiotics alone in preventing recurrence.

• Patients who have experienced two or more episodes of C. difficile infection (i.e., at least one recurrence) should be considered for treatment with fecal microbiota live – jslm.

• Rebyota™, a liquid suspension derived from donor stool, can be administered in the office rectally, and does not require bowel preparation, an invasive procedure, fasting or sedation.

• Rebyota™ is not indicated for treatment of conditions other than recurrent C. difficile infection such as inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, cirrhosis, celiac disease or obesity.

Keywords: :

• Fecal microbiota transplantation
• microbiome
• microbiota restoration therapy
• RBL
• RBX2660
• recurrence
• recurrent C. difficile infection

Financial disclosure

S Khanna: Research grants from Rebiotix, Inc (A Ferring company), Seres, Finch, Vedanta and consulting fees from Takeda, Immuron, Niche and ProbioTech Inc, outside of the submitted work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.