An interventional study of Characterization the fecal microbiome composition in travelers in Microbiome, Metagenomic Next Generation Sequencing and Norovirus Infection, sponsored by IRCCS Sacro Cuore Don Calabria di Negrar. Active, not recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by IRCCS Sacro Cuore Don Calabria di Negrar · Not applicable, Interventional, and Screening
The goal of this clinical trial is to characterize the fecal microbiome composition (including bacteria, archaea, viruses, fungi, and parasites) in fecal samples collected from travelers (including occupational travelers, leisure travelers, Visiting Friends and relatives (VFR), and migrants) attending the center,
This is a exploratory, experimental study using samples archived in the local biobank which involves analyses such as metagenomic and metatranscriptomic analyses of fecal samples.
This is a exploratory, experimental clinical trial characterize the fecal microbiome composition (including bacteria, archaea, viruses, fungi, and parasites) in fecal samples collected between January 2017 to April 2026 from travelers (including occupational travelers, leisure travelers, Visiting Friends and relatives (VFR), and migrants).The study will also estimate the prevalence of Norovirus infection in fecal samples collected from the same population.
This pilot study aim at investigating the fecal microbiome in patients with a travel history through combined metagenomic and metatranscriptomic analyses of fecal samples.
The analyses conducted will be nucleic acid extraction and sequencing for both metagenomic and metatranscriptomic library preparation and then a bioinformatics database will be created.
22 studies on the registry are indexed under Caliciviridae Infections; 2 are open to participants now.
This study's planned enrollment of 100 is above the median of 63 across 20 interventional studies indexed under Caliciviridae Infections.
Browse Caliciviridae Infections studies →IRCCS Sacro Cuore Don Calabria di Negrar is the lead sponsor of 37 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Characterization the fecal microbiome composition in travelers fecal samples through combined metagenomic and metatranscriptomic analyses
Other: Characterization the fecal microbiome composition in travelers
Analysis of traverlers' fecal samples through nucleic acid extraction and sequencing, followed by metagenomic and metatranscriptomic library preparation. Raw sequencing reads from metagenomic and metatranscriptomic datasets will first undergo quality assessment using tools such as FastQC. Taxonomic profiling will be performed to characterize the full microbial community, including bacteria, archaea, viruses, fungi, and parasites. This will be achieved using complementary approaches such as k-mer-based classification and marker gene-based methods. Functional profiling of microbial communities will be conducted using tools such as HUMAnN, enabling the reconstruction of metabolic pathways and functional potential from metagenomic and metatranscriptomic data.
Prevalence of Norovirus infection
Proportion of fecal samples testing positive for Norovirus RNA by sequencing assay.
Time frame: Baseline
Characterization of fecal microbiome composition
Characterization of fecal microbiome composition in fecal samples using alpha diversity metrics (Shannon Index H' and Simpson D diversity indexes) as assessed by metagenomics and metatranscriptomics
Time frame: 18 Month from Baseline
Characterization of fecal microbiome composition
Characterization of relative abundance of microbial taxa (bacteria, archaea, viruses, fungi, parasites) in fecal microbiome as assessed by metagenomics and metatranscriptomics
Time frame: 18 Month from Baseline
Identification of associations between Norovirus infection status and microbial genomic and transcriptomic data
Identification of associations between Norovirus infection status (yes/no) in travelers' fecal samples and microbial genomic and transcriptomic data, as well as routine diagnostic (pathogen detection data as yes/no), demographic (gender as Male/Female, age as years and ethnicity as country of birth), and travel-related variables
Time frame: 18 Month from Baseline
Identification of distinct microbial genomic and transcriptomic patterns
Identification of distinct microbial genomic and transcriptomic patterns (clusters or signatures) in fecal samples from travelers together with clinical (symptoms as yes/no), demographic (gender as Male/Female and age as years), and environmental variables
Time frame: 18 Month from Baseline
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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IRCCS Sacro Cuore Don Calabria di Negrar