BACKGROUND: Faecal microbiota transplantation (FMT) is the standard treatment for patients with multiple recurrent Clostridioides difficile infection (rCDI). Recently, new commercially developed human microbiota-derived medicinal products have been evaluated and Food and Drug Administration-approved with considerable differences in terms of composition, administration, and targeted populations. OBJECTIVES: To review available data on the different microbiota-derived treatments at the stage of advanced clinical evaluation and research in rCDI in comparison with FMT. SOURCES: Phase II or III trials evaluating a microbiota-derived medicinal product to prevent rCDI. CONTENT: Two commercial microbiota-derived medicinal products are approved by the Food and Drug Administration: Rebyota (RBX2660 Ferring Pharmaceuticals, marketed in the United States) and VOWST (SER-109 -Seres Therapeutics, marketed in the United States), whereas VE303 (Vedanta Biosciences Inc) will be studied in phase III trial. RBX2660 and SER-109 are based on the processing of stools from healthy donors, whereas VE303 consists of a defined bacterial consortium originating from human stools and produced from clonal cell banks. All have proven efficacy to prevent rCDI compared with placebo in patients considered at high risk of recurrence. However, the heterogeneity of the inclusion criteria, and the time between each episode and CDI diagnostics makes direct comparison between trials difficult. The differences regarding the risk of recurrence between the treatment and placebo arms were lower than previously described for FMT (FMT: Δ = 50.5%; RBX2660-phase III: Δ = 13.1%; SER-109-phase III: Δ = 28%; high-dose VE303-phase-II: Δ = 31.7%). All treatments presented a good overall safety profile with mainly mild gastrointestinal symptoms. IMPLICATIONS: Stool-derived products and bacterial consortia need to be clearly distinguished in terms of product characterization and their associated risks with specific long-term post-marketing evaluation similar to registries used for FMT. Their place in the therapeutic strategy for patients with rCDI requires further studies to determine the most appropriate patient population and administration route to prevent rCDI.

Department of Medical Microbiology 2nd Faculty of Medicine Charles University and Motol University Hospital Prague Czech Republic

Department of Medical Microbiology Center for Microbiota Analysis and Therapeutics at Leiden University Medical Centre Albinusdreef 2 Leiden The Netherlands

Departments of Clinical Microbiology Royal College of Surgeons in Ireland and Beaumont Hospital Dublin Ireland

ESGCD

ESGHAMI

Faculty of Biological Sciences University of Leeds Leeds United Kingdom

French Fecal Transplant Group France

Healthcare Associated Infections Research Group Leeds Teaching Hospitals NHS Trust and University of Leeds Leeds United Kingdom

Hepato Gastroenterology Department Hôpital de la Croix Rousse Hospices Civils de Lyon CRCL Lyon France

Lyon GEM Microbiota Study Group Lyon France

Member of the European Fecal Microbiota Transplantation Network

National Reference Laboratory for Clostridioides difficile AP HP Hôpital Saint Antoine Paris France

Patient representative ESCMID Study Group for Clostridioides difficile

Pharmabiotic Research Institute Narbonne France

Service of Infectious Diseases Lausanne University Hospital and University of Lausanne Lausanne Switzerland

Université Paris Cité INSERM UMR 1139 Paris France

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