Clinical trial NCT06568380: Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak
Official title: Investigation of Norovirus Infection Incidence According to the Presence of Fecal Bacteriophages After Oyster Consumption : Randomized Controlled Clinical Trial - VIROYSTER
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroenteritis Norovirus
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Norovirus concentration in feces (genome copy number/grammes of feces)
timeFrame: Baseline (J0) and during symptoms if any or within 36-60 hours after consumption in another case
measure: Gastroenteritis symptoms
timeFrame: within 3 days after consumption
measure: Immunoglobulin A (IgA) detection in feces
timeFrame: within 3-5 days after consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
state: Lorraine
Study officials:
affiliation: LCPME -UMR Université de Lorraine/CNRS
name: Christophe Gantzer, Pr
role: STUDY_DIRECTOR
References: