Gastroenteritis NorovirusVIROYSTERNCT06568380
Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak
A study testing Oyster consumption in people with Gastroenteritis Norovirus, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Noroviruses are responsible for 700M of annual cases of gastroenteritis, of which 15M are directly related to the consumption of contaminated food, including oysters. Current regulations do not require control of human noroviruses in shellfish. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroenteritis Norovirus
- What is being tested?
- Oyster consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2020to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent signed
- Health status
- No seafood allergy
- Nancy city residents
Who cannot join
- Recent gastroenteritis (<6 months)
- Fragile health person proximity
- Oysters consumption during the study
- Pregnancy or breastfeeding
- "nonsecretor" phenotype
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Norovirus Infection Incidence According to the Presence of Fecal Bacteriophages After Oyster Consumption : Randomized Controlled Clinical Trial - VIROYSTER
Noroviruses are responsible for 700M of annual cases of gastroenteritis, of which 15M are directly related to the consumption of contaminated food, including oysters. Current regulations do not require control of human noroviruses in shellfish. However, an ISO standard recommended to detect their genome in high-risk foodstuffs. However, presence of viral genome doesn't testify to the presence of infectious particles. Routine application of this standard would therefore wrongly lead to the withdrawal of shellfish from market, since norovirus genomes are widely found in the environment and in food without indicating a viral risk. Given the difficulty of cultivating human noroviruses in vitro and thus of discriminating infectious particles from non-infectious particles only based on genome detection, it is necessary to identify an indicator of the infectious nature of these pathogenic viruses. To be suitable, the indicator must first be associated with the presence of norovirus genome in the environment. This is the case of fecal bacteriophage F-specific RNA. Since bacteriophages are cultivable in the laboratory, it is easy to estimate the proportion of genomes of these bacteriophages corresponding to infectious particles. To confirm this indicator, it is necessary to demonstrate a relationship between the presence of infectious bacteriophages with that of infectious norovirus. This is only estimable by the occurrence of a gastroenteritis after consumption of a contaminated food by humans. We propose this randomized controlled clinical trial to evaluate the incidence of norovirus infection after consumption of oysters free from or containing infectious F-specific RNA bacteriophages.
The purpose of this study is to evaluate if norovirus infections incidence is significantly weak after the consumption of oysters free of F-specific infectious RNA bacteriophages, compared to the consumption of oysters containing these same infectious bacteriophages.
- Conditions
- Gastroenteritis Norovirus
- Being tested
- Oyster consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oyster consumptionOther
Volunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-).
| Study group | Role | What they receive |
|---|---|---|
| Noro+ Phage+ | Experimental | Oysters positives for both norovirus genome and infectious bacteriophages Receives: Other: Oyster consumption |
| Noro+ Phage- | Experimental | Oysters positives for norovirus genome and negatives for infectious bacteriophages Receives: Other: Oyster consumption |
| Noro- Phage+ | Experimental | Oysters negatives for norovirus genome and positives for infectious bacteriophages Receives: Other: Oyster consumption |
| Noro- Phage- | Placebo comparator | Oysters negatives for both norovirus genome and infectious bacteriophages Receives: Other: Oyster consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Norovirus concentration in feces (genome copy number/grammes of feces)
A norovirus genome augmentation may indicate virus replication
Measured: Baseline (J0) and during symptoms if any or within 36-60 hours after consumption in another case
Gastroenteritis symptoms
Measured: within 3 days after consumption
Immunoglobulin A (IgA) detection in feces
In case of asymptomatic infection, IgA are secreted
Measured: within 3-5 days after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study startJan 2020 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Why it stopped: study abandoned before authorization obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteritis NorovirusStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Gantzer, Pr, Study director, LCPME -UMR Université de Lorraine/CNRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568380
- Sponsor's protocol ID
- 2019-A01763-54
- Acronym
- VIROYSTER
- Status last verified
- Aug 2024
- First submitted
- 23 Sep 2019
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Norovirus Infection Incidence According to the Presence of Fecal Bacteriophages After Oyster Consumption : Randomized Controlled Clinical Trial - VIROYSTER
- ClinicalTrials.gov ID
- NCT06568380
- Acronym / sponsor ID
- VIROYSTER / 2019-A01763-54
- Conditions
- Gastroenteritis Norovirus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study abandoned before authorization obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 23 Aug 2024 (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.
Noroviruses are responsible for 700M of annual cases of gastroenteritis, of which 15M are directly related to the consumption of contaminated food, including oysters. Current regulations do not require control of human noroviruses in shellfish. However, an ISO standard recommended to detect their genome in high-risk foodstuffs. However, presence of viral genome doesn't testify to the presence of infectious particles. Routine application of this standard would therefore wrongly lead to the withdrawal of shellfish from market, since norovirus genomes are widely found in the environment and in food without indicating a viral risk. Given the difficulty of cultivating human noroviruses in vitro and thus of discriminating infectious particles from non-infectious particles only based on genome detection, it is necessary to identify an indicator of the infectious nature of these pathogenic viruses. To be suitable, the indicator must first be associated with the presence of norovirus genome in the environment. This is the case of fecal bacteriophage F-specific RNA. Since bacteriophages are cultivable in the laboratory, it is easy to estimate the proportion of genomes of these bacteriophages corresponding to infectious particles. To confirm this indicator, it is necessary to demonstrate a relationship between the presence of infectious bacteriophages with that of infectious norovirus. This is only estimable by the occurrence of a gastroenteritis after consumption of a contaminated food by humans. We propose this randomized controlled clinical trial to evaluate the incidence of norovirus infection after consumption of oysters free from or containing infectious F-specific RNA bacteriophages.
The purpose of this study is to evaluate if norovirus infections incidence is significantly weak after the consumption of oysters free of F-specific infectious RNA bacteriophages, compared to the consumption of oysters containing these same infectious bacteriophages.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Noro+ Phage+ | Experimental | Other: Oyster consumptionOysters positives for both norovirus genome and infectious bacteriophages |
| Noro+ Phage- | Experimental | Other: Oyster consumptionOysters positives for norovirus genome and negatives for infectious bacteriophages |
| Noro- Phage+ | Experimental | Other: Oyster consumptionOysters negatives for norovirus genome and positives for infectious bacteriophages |
| Noro- Phage- | Placebo comparator | Other: Oyster consumptionOysters negatives for both norovirus genome and infectious bacteriophages |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent signed
- Health status
- No seafood allergy
- Nancy city residents
Key exclusion criteria (5 listed)
- Recent gastroenteritis (<6 months)
- Fragile health person proximity
- Oysters consumption during the study
- Pregnancy or breastfeeding
- "nonsecretor" phenotype
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 |
|---|---|---|
| Oyster consumptionVolunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-). | Other | Noro+ Phage+, Noro+ Phage-, Noro- Phage+, Noro- Phage- |
Primary outcome
Norovirus concentration in feces (genome copy number/grammes of feces)
Time frame: Baseline (J0) and during symptoms if any or within 36-60 hours after consumption in another case
A norovirus genome augmentation may indicate virus replication
Gastroenteritis symptoms
Time frame: within 3 days after consumption
Immunoglobulin A (IgA) detection in feces
Time frame: within 3-5 days after consumption
In case of asymptomatic infection, IgA are secreted
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Gastroenteritis Norovirus
RecruitingPhase 1
A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis
Norovirus Infections, Norovirus Gastroenteritis
Active, not recruitingPhase 3
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Acute Gastroenteritis, Norovirus Acute Gastroenteritis
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.
Christophe Gantzer, Pr study director
LCPME -UMR Université de Lorraine/CNRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oyster consumption in people with Gastroenteritis Norovirus, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Aug 2024. 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 France. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Norovirus concentration in feces (genome copy number/grammes of feces) (time frame: Baseline (J0) and during symptoms if any or within 36-60 hours after consumption in another case). 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 23 Aug 2024.