REPhRAME Launches Europe's Largest Clinical Trial Combining Phage Therapy and Microbiome Restoration for Recurrent Urinary Tract Infections

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Recurrent urinary tract infections remain one of the most persistent bacterial diseases worldwide, affecting an estimated 400 to 450 million people every year and generating billions of euros in healthcare costs. In Europe alone, urinary tract infections account for more than 10 million medical consultations annually, with a significant proportion involving recurrent cases. These infections disproportionately affect women, with nearly 50 to 60 percent experiencing at least one episode during their lifetime and up to 30 percent developing recurrent infections. 

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A major European initiative hopes to change this landscape. The REPhRAME project, coordinated by Universitätsmedizin Frankfurt under the leadership of Professor Maria J.G.T. Vehreschild, has secured €15 million through the Horizon Europe research programme to evaluate an entirely new therapeutic strategy. Running over five years from June 2026, the project will conduct the first randomized clinical trial investigating the sequential use of bacteriophage therapy followed by restoration of the intestinal microbiome for patients suffering from recurrent urinary tract infections.

The scientific rationale behind this approach is based on the intimate relationship between the gut microbiota and recurrent urinary tract infections. Most infections originate from intestinal strains of Escherichia coli that later colonize the urinary tract. While antibiotics temporarily eliminate susceptible bacteria, they also disturb the normal intestinal microbial community, reducing colonization resistance and allowing pathogenic strains to persist or re-establish themselves. This repeated cycle of infection, antibiotic exposure and reinfection has become increasingly difficult to interrupt.

To overcome this challenge, REPhRAME combines two complementary therapeutic strategies. The first relies on SNIPR001, a CRISPR-engineered bacteriophage cocktail developed by the Danish biotechnology company SNIPR Biome. Unlike conventional antibiotics, bacteriophages specifically infect their bacterial targets while largely preserving the surrounding microbiota. SNIPR001 has been designed to selectively eliminate pathogenic Escherichia coli strains responsible for recurrent urinary tract infections while minimizing the emergence of new resistance mechanisms.

The second stage of treatment focuses on rebuilding the intestinal microbial ecosystem. Patients will receive INTESTIFIX 001, a microbiota restoration therapy developed by the Cologne Microbiota Bank, using carefully screened donor microbiota to restore bacterial diversity and reinforce the natural protective functions of the gut microbiome. By combining targeted bacterial elimination with microbiome recovery, researchers hope to provide durable protection against recurrent infections rather than simply treating individual episodes.

The clinical programme will compare three therapeutic strategies: phage therapy alone, phage therapy combined with antibiotics, and phage therapy followed by microbiome restoration. In addition to evaluating safety and clinical efficacy, the trial is expected to generate the evidence required to support future regulatory approval and broader implementation of phage therapy across Europe.

Beyond the clinical study, REPhRAME incorporates an extensive translational research programme. Scientists will investigate how therapeutic phages circulate within the human body, how they interact with the immune system, and how the intestinal microbiome evolves throughout treatment. Artificial intelligence will be employed to identify patient characteristics associated with the greatest likelihood of therapeutic success, while health-economic analyses and patient-reported outcome studies will evaluate the feasibility of integrating these innovative therapies into routine clinical care.

The consortium itself reflects the multidisciplinary nature of modern phage research. Alongside Universitätsmedizin Frankfurt, the project brings together expertise from the Fraunhofer-Gesellschaft, the German Center for Infection Research, Hannover Medical School, LINQ management GmbH and the University Hospital Cologne in Germany. Additional partners include SNIPR Biome in Denmark, the HUN-REN Biological Research Centre in Hungary, Riga Stradiņš University in Latvia, Leiden University Medical Center in the Netherlands, JAFRAL in Slovenia, the Swiss Institute of Bioinformatics together with the Universities of Bern and Zurich in Switzerland, and the Universities of Leicester and Reading in the United Kingdom. Together, these sixteen institutions combine expertise spanning infectious diseases, microbiology, phage therapy, microbiome science, bioinformatics, regulatory science and clinical trial management.

By integrating precision bacteriophage therapy with microbiome restoration, REPhRAME seeks to establish a new paradigm for managing recurrent urinary tract infections. If successful, the project could significantly reduce antibiotic consumption, decrease recurrence rates and provide one of the strongest clinical demonstrations to date that phage-based therapeutics can become part of routine medical practice in Europe.


Source : https://www.uni-frankfurt.de/en/newsroom/meldungen/pressemitteilungen/2026/mit-viren-gegen-bakterien-15-millionen-fuer-phagentherapie

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