Trials Sponsors Conditions Drugs Pricing

Conditions

Metagenomic Next Generation Sequencing Microbiome Norovirus Infection

Keywords

microbiomemetagenomic next generation sequencingmetatranscriptomic analysestravelers

Outcome Measures

Primary Outcomes (3)

Prevalence of Norovirus infection
Proportion of fecal samples testing positive for Norovirus RNA by sequencing assay.
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
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
18 Month from Baseline

Study Arms (1)

Characterization the fecal microbiome composition in travelers

EXPERIMENTAL

Characterization the fecal microbiome composition in travelers fecal samples through combined metagenomic and metatranscriptomic analyses

Other: Characterization the fecal microbiome composition in travelers

Interventions

Characterization the fecal microbiome composition in travelersOther

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.

Characterization the fecal microbiome composition in travelers

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Travelers, migrants, and Visiting Friends and Relatives returning from international travel who provided fecal samples as part of routine diagnostic procedures at the local Center
No age restriction.

Sponsors & Collaborators

IRCCS Sacro Cuore Don Calabria di Negrar
Otherlead

Study Sites (1)

IRCCS Sacro Cuore Don Calabra Hospital

Negrar, Verona, 37024, Italy

MeSH Terms

Conditions

Caliciviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SCREENING
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 29, 2026

First Posted

October 8, 2026

Study Start

July 28, 2026

Actual (reported)

Primary Completion

January 28, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Norovirus Prevalence and Fecal Microbiome Characterization Through Metagenomic and Metatranscriptomic Analyses

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Characterization the fecal microbiome composition in travelers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Secondary Outcomes (1)

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (1)

Characterization the fecal microbiome composition in travelers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Secondary Outcomes (1)

Other Outcomes (1)

You may not qualify if:

Data Sharing

Source record

Locations