MicrobiomeMETATRAVNCT07866469
Norovirus Prevalence and Fecal Microbiome Characterization Through Metagenomic and Metatranscriptomic Analyses
A study testing Characterization the fecal microbiome composition in travelers in people with Microbiome and Metagenomic Next Generation Sequencing, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Microbiome, Metagenomic Next Generation Sequencing, Norovirus Infection
- What is being tested?
- Characterization the fecal microbiome composition in travelers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jul 2026to 28 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Signed informed consent to the donation of residual material to Local Biobank
Who cannot join
- Unavailable fecal sample
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norovirus Prevalence and Fecal Microbiome Characterization Through Integrated Metagenomic and Metatranscriptomic Analyses in Patients With a Travel History
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.
Read the detailed description
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.
- Being tested
- Characterization the fecal microbiome composition in travelers
- Keywords
- microbiome, metagenomic next generation sequencing, metatranscriptomic analyses, travelers
- Medical subject headings
- Caliciviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Characterization the fecal microbiome composition in travelers | Experimental | Characterization the fecal microbiome composition in travelers fecal samples through combined metagenomic and metatranscriptomic analyses Receives: Other: Characterization the fecal microbiome composition in travelers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Norovirus infection
Proportion of fecal samples testing positive for Norovirus RNA by sequencing assay.
Measured: 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
Measured: 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
Measured: 18 Month from Baseline
Secondary outcomes (1)
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
Measured: 18 Month from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start28 Jul 2026
- Primary completion28 Jan 2028 (estimated)
- Study completion28 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866469
- Sponsor's protocol ID
- 2026-24
- Acronym
- METATRAV
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norovirus Prevalence and Fecal Microbiome Characterization Through Integrated Metagenomic and Metatranscriptomic Analyses in Patients With a Travel History
- ClinicalTrials.gov ID
- NCT07866469
- Acronym / sponsor ID
- METATRAV / 2026-24
- Keywords
- microbiome, metagenomic next generation sequencing, metatranscriptomic analyses, travelers
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 28 Jan 2028 (estimated)
- Study completion
- 28 Jul 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Characterization the fecal microbiome composition in travelers | Experimental | Other: Characterization the fecal microbiome composition in travelersCharacterization the fecal microbiome composition in travelers fecal samples through combined metagenomic and metatranscriptomic analyses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- Signed informed consent to the donation of residual material to Local Biobank
Key exclusion criteria (1 listed)
- Unavailable fecal sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Characterization the fecal microbiome composition in travelersAnalysis 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. | Other | Characterization the fecal microbiome composition in travelers |
Primary outcome
Prevalence of Norovirus infection
Time frame: Baseline
Proportion of fecal samples testing positive for Norovirus RNA by sequencing assay.
Characterization of fecal microbiome composition
Time frame: 18 Month from Baseline
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
Characterization of fecal microbiome composition
Time frame: 18 Month from Baseline
Characterization of relative abundance of microbial taxa (bacteria, archaea, viruses, fungi, parasites) in fecal microbiome as assessed by metagenomics and metatranscriptomics
1 secondary outcome
Identification of associations between Norovirus infection status and microbial genomic and transcriptomic data
Time frame: 18 Month from Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Characterization the fecal microbiome composition in travelers in people with Microbiome and Metagenomic Next Generation Sequencing, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Norovirus infection (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.