Advancing therapeutics for recurrent clostridioides difficile Infections: an overview of vowst's FDA approval and implications

Nityanand Jain (Coresponding Author), Tungki Pratama Umar, Anne Fleur Fahner, Valdis Ģībietis

Research output: Contribution to journalArticlepeer-review


Clostridioides difficile infections (CDI) are a leading cause of healthcare-associated infections with a high relapse rate. Current treatment guidelines recommend fidaxomicin as the primary therapy for initial CDI episodes and suggest alternative approaches for recurrent episodes, including fecal microbiota transplantation (FMT). This paper explores the recent approval of Vowst, a novel oral FMT drug, by the United States Food and Drug Administration (FDA) as a prophylactic therapy to prevent recurrent CDIs. Vowst comprises a formulation of live fecal microbiota spores and works by re-establishing the disrupted gut microbiota, limiting C. difficile spore germination, and promoting microbiome repair. Furthermore, this paper will discuss the product’s approval journey and the uncertainties regarding its efficacy in CDI patients beyond the ones who participated in the clinical trials, pharmacovigilance, cost estimates, and the need for a more stringent donor screening process. Overall, Vowst’s approval marks a significant step forward in the prevention of recurrent CDI infections with various beneficial implications for future gastroenterology.
Original languageEnglish
Article number2232137
Number of pages10
JournalGut Microbes
Issue number1
Publication statusPublished - 11 Jul 2023


  • Clostridium difficile
  • oral
  • Fecal microbiota transplantation
  • recurrent
  • infections
  • gastroenterology
  • pharmacovigilance
  • Vowst
  • SER-109
  • fecal microbiota

Field of Science*

  • 3.1 Basic medicine
  • 3.4 Medical biotechnology
  • 3.3 Health sciences

Publication Type*

  • 1.1. Scientific article indexed in Web of Science and/or Scopus database


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