Project

VRE-ex: Efficacy of Fecal Microbiota Transfer for VRE eradication in immunocompromised patients

Short description

Patients colonized with vancomycin-resistant enterococci (VRE)—particularly immunocompromised patients—are at increased risk of developing subsequent VRE infections. Repeated antibiotic therapies are not an option for decolonization in patients receiving immunosuppressive therapy, as antibiotic-induced selection pressure may promote the further spread of multidrug-resistant enterococci. Effective and sustainable strategies for reducing or eradicating VRE colonization in this patient group are still lacking. This randomized, placebo-controlled, double-blind clinical trial aims to investigate the efficacy and safety of Fecal Microbiota Transfer (FMT) for the eradication of VRE in patients receiving immunosuppressive therapy.

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Across three study arms, two different FMT regimens are compared with a placebo. The FMT products are manufactured under GMP conditions at the Cologne Microbiota Bank (CMB).

The primary endpoint is the rate of VRE decolonization 30 days after a two-dose FMT compared with placebo. Secondary endpoints include comparing the effects of two-dose and single-dose FMT. Additional research questions address long-term eradication through day 180, reduction of the intestinal VRE bacterial load, the occurrence of VRE-associated infections, changes in quality of life, oncological outcomes through day 180, microbiome alterations, and the safety of FMT in this indication.

Schematic overview of the VRE-ex study design.

© DZIF

In addition, stool and blood samples will be collected at various time points to analyze changes in the microbiome and immune activation in relation to VRE colonization and FMT treatment. These analyses—in conjunction with results from the RESET-MDR study— form the basis for future research aimed at understanding the mechanisms underlying successful FMT in this patient group.