EU Funds First Randomized Phage Therapy Trial with €15 Million to Combat Recurrent UTIs
核心洞察
The REPhRAME project, funded with €15 million through Horizon Europe, will conduct the first randomized clinical trial combining phage therapy with gut microbiome restoration to prevent recurrent urinary tract infections (搜索).
Led by Universitätsmedizin Frankfurt (搜索), the five-year study will compare phage therapy alone, phage therapy with antibiotics, and phage therapy followed by microbiome restoration across multiple European centers.
The phage cocktail SNIPR001, developed using CRISPR gene-editing technology, specifically targets E. coli strains while the microbiome restoration uses INTESTIFIX 001 (搜索) from healthy donor stool bacteria.
A landmark European research initiative has been awarded €15 million to conduct the first-ever randomized clinical trial evaluating a two-step therapeutic strategy combining phage therapy with gut microbiome restoration to prevent recurrent urinary tract infections (搜索) (UTIs). The REPhRAME project, led by Universitätsmedizin Frankfurt (搜索), launched in June 2026 and will run for five years under the European Union's Horizon Europe research and innovation program.
Recurrent UTIs represent one of the most common bacterial infections globally, with more than 400 million people affected each year. In 30 to 50 percent of cases, the infection recurs, creating a vicious cycle of infection, antibiotic treatment, and reinfection that drives antimicrobial resistance. "Recurrent urinary tract infections (搜索) place a substantial burden on patients and healthcare systems, yet existing treatment options are simply insufficient for many affected individuals," said Prof. Dr. Maria J.G.T. Vehreschild, Head of Infectious Diseases at Universitätsmedizin Frankfurt (搜索) and overall coordinator of the project.
A Dual-Action Strategy Against Recurrent Infection
The REPhRAME approach breaks from conventional antibiotic-centered treatment by deploying two sequential interventions. The first step employs SNIPR001, a CRISPR-armed phage cocktail developed to specifically target certain strains of Escherichia coli, the intestinal bacterium responsible for the majority of UTIs. Unlike broad-spectrum antibiotics, phages act with high specificity, attacking only the target bacteria while preserving much of the natural microbiota.
The second step focuses on microbiome restoration using INTESTIFIX 001 (搜索), a product of the Cologne Microbiota Bank (搜索) that transfers stool bacteria from healthy donors to re-establish the natural balance of the intestinal microbiota. The goal is to provide long-term protection against recurrent infections by addressing the underlying dysbiosis that may predispose patients to reinfection.
Trial Design and Clinical Evaluation
At the heart of REPhRAME is a multicenter clinical trial spanning multiple European countries that will systematically evaluate the safety and effectiveness of the new treatment paradigm. Three distinct approaches will be compared: phage therapy alone, phage therapy combined with antibiotics, and phage therapy followed by microbiome restoration.
"REPhRAME aims to transform phage therapy from a promising research concept into a clinically validated treatment option—with robust data on safety, efficacy, and implementation. In doing so, we hope to lay the foundation for integrating phage therapy into routine medical practice across Europe," Vehreschild added. She also serves as a scientist at the German Center for Infection Research (搜索) (DZIF) and deputy coordinator of the DZIF research area Healthcare-Associated Infections.
An International Consortium of 16 Partners
The consortium, coordinated by Universitätsmedizin Frankfurt (搜索), brings together 16 partners from academia, clinical research, and industry across eight European countries. Participating institutions include SNIPR Biome (搜索) (Denmark), Fraunhofer-Gesellschaft (Germany), the German Center for Infection Research (搜索) (Germany), Hannover Medical School (Germany), LINQ management GmbH (Germany), University Hospital Cologne (Germany), HUN-REN Biological Research Centre (Hungary), Riga Stradiņš University (Latvia), Leiden University Medical Center (Netherlands), Jafral (Slovenia), the Swiss Institute of Bioinformatics (Switzerland), University of Bern (Switzerland), University of Zurich (Switzerland), University of Leicester (United Kingdom), and University of Reading (United Kingdom).
Together, these partners combine expertise in infectious diseases, clinical trials, phage therapy, microbiome research, microbiology, bioinformatics, regulatory science, drug development, and patient-centered research.
Building on Frankfurt's Legacy in Infection Research
Prof. Dr. Jürgen Graf, Medical Director and Chief Executive Officer of Universitätsmedizin Frankfurt (搜索), emphasized the institution's leadership role: "Phage therapy is one of the most promising responses to the growing challenge posed by multidrug-resistant pathogens. The fact that Universitätsmedizin Frankfurt is leading this international consortium under the direction of Professor Vehreschild once again demonstrates our institution's outstanding role in translational infection research."
Prof. Dr. Enrico Schleiff, President of Goethe University, connected the project to Frankfurt's historic contributions to antimicrobial science: "By developing new therapies against bacterial pathogens, we are continuing the legacy of Paul Ehrlich, who discovered the first antibiotic in Frankfurt and thereby initiated medicine's successful fight against infectious diseases. Yet biology never stands still, and in the face of increasing bacterial resistance, Goethe University is vigorously pursuing new holistic treatment concepts."
The REPhRAME project has the potential to significantly reduce antibiotic use, lower the number of recurrent infections, and sustainably improve the quality of life for many patients. At the same time, it will establish the scientific and regulatory foundations needed to bring phage-based therapies more broadly into clinical practice in the future.