Jain, NityanandUmar, Tungki PratamaFahner, Anne FleurĢībietis, Valdis2023-07-252023-07-252023-07-11Jain, N, Umar, T P, Fahner, A F & Ģībietis, V 2023, 'Advancing therapeutics for recurrent clostridioides difficile Infections : an overview of vowst's FDA approval and implications', Gut Microbes, vol. 15, no. 1, 2232137. https://doi.org/10.1080/19490976.2023.22321371949-0976https://dspace.rsu.lv/jspui/handle/123456789/14171Funding Information: The present paper did not receive any external funding and was self-supported by the authors. Publisher Copyright: © 2023 The Author(s). Published with license by Taylor & Francis Group, LLC.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.10338274enginfo:eu-repo/semantics/openAccessClostridium difficileoralFecal microbiota transplantationrecurrentinfectionsgastroenterologypharmacovigilanceVowstSER-109fecal microbiota3.1 Basic medicine3.4 Medical biotechnology3.3 Health sciences1.1. Scientific article indexed in Web of Science and/or Scopus databaseGeneral Immunology and MicrobiologyGeneral MedicinePharmacology, Toxicology and Pharmaceutics(all)SDG 3 - Good Health and Well-being/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article10.1080/19490976.2023.2232137http://www.scopus.com/inward/record.url?scp=85164299561&partnerID=8YFLogxKhttps://www.tandfonline.com/doi/full/10.1080/19490976.2023.2232137