A Multicenter Prospective Protocol to Explore the Relationship Between Enterococcus faecalis Bloodstream Infections and Colorectal Neoplasms (EnteroColonus-GAMES Project)

Preliminary evidence suggests that patients with Enterococcus faecalis bacteremia and infective endocarditis, particularly those without an identifiable source, may have an increased prevalence of colorectal neoplasia. Whether systematic colonoscopy should be recommended in this population remains unresolved. EnteroColonus is a multicenter, prospective, observational matched cohort study that will recruit adults aged 50 years or older with E. faecalis bacteremia and/or infective endocarditis from 22 Spanish centers, together with asymptomatic controls undergoing colorectal cancer screening. Cases will be stratified into E. faecalis bacteremia/endocarditis of unknown origin (EFBEUO) and with suspected source (EFBESS). The original planned sample size initially was 414 participants: 276 cases and 138 matched controls. Under the amended protocol, the current confirmatory sample-size target is 165 participants (110 cases and 55 matched controls; 2:1 case-to-control allocation). Core procedures include colonoscopy, histopathology, clinical and microbiological phenotyping of colonic samples, fecal microbiome profiling by shotgun metagenomics, detection of E. faecalis genetic material in colorectal biopsy specimens using 16S sequencing and species-specific qPCR, and whole-genome, SNP, and phylogenetic analyses of clinical isolates. Secondary endpoints include microbiome profiles, biopsy positivity for E. faecalis, genomic traits of bloodstream isolates, mortality, relapse/recurrence, and development of a colorectal neoplasia risk score. This protocol is designed to clarify which patients with E. faecalis bloodstream infection might benefit from systematic colonoscopy evaluation and to explore host–microbe mechanisms underlying the observed association with colorectal neoplasia.

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Journal
Microorganisms
Published
2026-09-28
DOI
https://doi.org/10.3390/microorganisms14102178
Primary Topic
Infective Endocarditis Diagnosis and Management
Type
article
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article

A Multicenter Prospective Protocol to Explore the Relationship Between Enterococcus faecalis Bloodstream Infections and Colorectal Neoplasms (EnteroColonus-GAMES Project)

Rosa Escudero-Sánchez, María-Alexandra Cañas, Ángeles Rodríguez Esteban, Guillermo Cuervo et al.
Microorganisms
Infective Endocarditis Diagnosis and Management
article

A Multicenter Prospective Protocol to Explore the Relationship Between Enterococcus faecalis Bloodstream Infections and Colorectal Neoplasms (EnteroColonus-GAMES Project)

Rosa Escudero-Sánchez, María-Alexandra Cañas, Ángeles Rodríguez Esteban, Guillermo Cuervo, María Tasias, Sofía de la Villa, Oriol Ferret Gasch, César A. Arias, Asunción Moreno, Itziar Diego‐Yagüe, Oriol Careta, José María Miró, Jorge Calderón‐Parra, Patricia Muñóz, Martha Kestler, Marta Hernández‐Meneses, Rosa Blanes-Hernández, Lara García-Álvarez, Javier Moreno-García, Roger Paredes, Irina Luzko, Cristina García de la Mària, Lucía Boix-Palop, Claudia Nevado, M. Mar Alonso-Socas, Juan M. Pericàs, Miguel A. Goenaga
article en

Abstract

Preliminary evidence suggests that patients with Enterococcus faecalis bacteremia and infective endocarditis, particularly those without an identifiable source, may have an increased prevalence of colorectal neoplasia. Whether systematic colonoscopy should be recommended in this population remains unresolved. EnteroColonus is a multicenter, prospective, observational matched cohort study that will recruit adults aged 50 years or older with E. faecalis bacteremia and/or infective endocarditis from 22 Spanish centers, together with asymptomatic controls undergoing colorectal cancer screening. Cases will be stratified into E. faecalis bacteremia/endocarditis of unknown origin (EFBEUO) and with suspected source (EFBESS). The original planned sample size initially was 414 participants: 276 cases and 138 matched controls. Under the amended protocol, the current confirmatory sample-size target is 165 participants (110 cases and 55 matched controls; 2:1 case-to-control allocation). Core procedures include colonoscopy, histopathology, clinical and microbiological phenotyping of colonic samples, fecal microbiome profiling by shotgun metagenomics, detection of E. faecalis genetic material in colorectal biopsy specimens using 16S sequencing and species-specific qPCR, and whole-genome, SNP, and phylogenetic analyses of clinical isolates. Secondary endpoints include microbiome profiles, biopsy positivity for E. faecalis, genomic traits of bloodstream isolates, mortality, relapse/recurrence, and development of a colorectal neoplasia risk score. This protocol is designed to clarify which patients with E. faecalis bloodstream infection might benefit from systematic colonoscopy evaluation and to explore host–microbe mechanisms underlying the observed association with colorectal neoplasia.

MicroorganismsVol. 14(10)
Universitat Autònoma de Barcelona (ES), Houston Methodist (US), Instituto Cajal (ES), Hospital Universitario de Canarias (ES), Instituto de Salud Carlos III (ES), Hospital General Universitario Gregorio Marañón (ES), Hospital Universitari i Politècnic La Fe (ES), Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (ES), Biogipuzkoa Health Research Institute (ES), Vall d'Hebron Institut de Recerca (ES), Hospital Universitario Puerta de Hierro Majadahonda (ES), Hospital Clínic de Barcelona (ES), Corporació Sanitària Parc Taulí (ES), Osakidetza (ES), Vall d'Hebron Hospital Universitari (ES), Mútua Terrassa (ES), Hospital Universitario Central de Asturias (ES), Institute of Research and Innovation Parc Tauli (ES), Hospital San Pedro (ES), Donostiako Unibertsitate Ospitalea (ES), Center for Biomedical Research of La Rioja (ES), Hospital Universitari Germans Trias i Pujol (ES), Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES), Medical Research Network (US), Centro de Investigación Biomédica en Red Enfermedades Infecciosas (ES), Universitat de Barcelona (ES)
Good health and well-being
Openalex Percentile: Top 11%
Infective Endocarditis Diagnosis and Management
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