Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak (VIROYSTER)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lorraine
-
Nancy, Lorraine, France, 54000
- CHRU NANCY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Informed consent signed
- Health status
- No seafood allergy
- Nancy city residents
Exclusion Criteria:
- Recent gastroenteritis (<6 months)
- Fragile health person proximity
- Oysters consumption during the study
- Pregnancy or breastfeeding
- "nonsecretor" phenotype
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Noro+ Phage+
Oysters positives for both norovirus genome and infectious bacteriophages
|
Volunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-).
|
|
Experimental: Noro+ Phage-
Oysters positives for norovirus genome and negatives for infectious bacteriophages
|
Volunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-).
|
|
Experimental: Noro- Phage+
Oysters negatives for norovirus genome and positives for infectious bacteriophages
|
Volunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-).
|
|
Placebo Comparator: Noro- Phage-
Oysters negatives for both norovirus genome and infectious bacteriophages
|
Volunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline (J0) and during symptoms if any or within 36-60 hours after consumption in another case
|
|
Gastroenteritis symptoms
Time Frame: within 3 days after consumption
|
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
|
within 3-5 days after consumption
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Christophe Gantzer, Pr, LCPME -UMR Université de Lorraine/CNRS
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A01763-54
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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