Single-arm study | Effects of SER-109 as an investigational microbiome therapeutic in recurrent C. difficile infection

Summary: This was a phase 3, open-label, single-arm trial of 263 adults with recurrent Clostridioides difficile Infection (CDI). The trial aimed to evaluate the safety and rate of CDI recurrence after administration of the investigational microbiome therapeutic SER-109. The trial found that SER-109 was well tolerated and the overall rate of recurrent CDI was low, regardless of the number of prior recurrences, demographics, or diagnostic approach.

(By ChatGPT, reviewed and edited)

Article: Safety and Tolerability of SER-109 as an Investigational Microbiome Therapeutic in Adults With Recurrent Clostridioides difficile Infection: A Phase 3, Open-Label, Single-Arm Trial – JAMA Network Open

Commentary: Phase 3 trial provides more positive data for recurrent C diff microbiome drug – CIDRAP

Related:

RCT: Among patients with recurrent Clostridioides difficile infection, the use of SER-109, an oral microbiome therapy, reduced recurrence rate compared to placebo (12% vs. 40%).

Post-trial follow-up | Microbiome therapeutic SER-109 through 24 weeks for recurrent Clostridioides difficile infection.