REcurrent urinary tract infection: Efficacy and safety of PHage theRapy and Microbiota transfEr

Recurrent urinary tract infections (rUTIs) impose a substantial clinical and socio-economic burden, particularly in women, and are increasingly complicated by antimicrobial resistance (AMR). Current treatment options rely heavily on antibiotics, fueling resistance and limiting therapeutic efficacy. The REPhRAME project addresses this unmet need by evaluating innovative, non-antibiotic strategies: a bacteriophage-based investigational medicinal product for acute treatment, and fecal microbiota transplantation (FMT-IMP) to prevent recurrence. Building on a seamless Phase Ib/IIa randomized controlled trial, the study will determine optimal routes of administration, assess efficacy in reducing antibiotic use, and evaluate recurrence prevention. Multi-omics analyses, biomarker discovery, and health economic modelling complement the clinical trial, while patient engagement, ethical oversight, and regulatory alignment ensure societal relevance and translational impact. By integrating precision medicine, novel biologics manufacturing, and robust clinical evidence, REPhRAME aims to pioneer sustainable alternatives to antibiotics, improving quality of life and supporting EU goals in AMR mitigation and healthcare innovation.