A Randomized controlled open-label phase II trial assessing the efficacy and safety of two-dosing regimens of frozen encapsulated fecal microbiota transfer products with or without an individualized donor selection approach in decolonizing carriers of multi-drug resistant Enterobacteriaceae (RESET-MDR)

Infections with multidrug-resistant Enterobacteriaceae

Detectable intestinal carriage of MDR-E at day 30 in standard qualitative cultural assessment

• Comparison of safety and tolerability data between groups via review of nature, frequency and severity of adverse events (AEs), serious AEs (SAEs), and new medical conditions for 30 days, • Characterization of changes in bacterial and fungal intestinal microbiota community structures and taxonomic classification (α- and ß-diversity) at day 0 compared to day 4, 12, 30 and 90, • Comparison of intestinal carriage of MDR-E at day 30 in quantitative cultural assessment, • Characterization and differences of patterns in the intestinal microbiota distribution in patients at baseline compared to day 4, 12, 30 and 90 with and without successful decolonization, • Rate of bacterial infections until day 90, • Rate of MDR-E infections until day 90, • Rate of any type of infection (bacteria, viruses, fungi, parasites) until day 90, • Rate of hospitalization and all-cause mortality until day 90

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Germany