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Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak

NCT06568380 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-08-23

No results posted yet for this study

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.

Conditions

  • Gastroenteritis Norovirus

Interventions

OTHER

Oyster consumption

Volunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-).

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Christophe Gantzer, Pr · LCPME -UMR Université de Lorraine/CNRS

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568380 on ClinicalTrials.gov