An interventional study of Oyster consumption in Gastroenteritis Norovirus, sponsored by Central Hospital, Nancy, France. Withdrawn at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Health services research
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.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oysters positives for both norovirus genome and infectious bacteriophages
Other: Oyster consumption
Oysters positives for norovirus genome and negatives for infectious bacteriophages
Other: Oyster consumption
Oysters negatives for norovirus genome and positives for infectious bacteriophages
Other: Oyster consumption
Oysters negatives for both norovirus genome and infectious bacteriophages
Other: Oyster consumption
Volunteers consume one of the four panel of oysters (Noro+Phage+, Noro+Phage-, Noro-Phage+ and Noro-Phage-).
Norovirus concentration in feces (genome copy number/grammes of feces)
A norovirus genome augmentation may indicate virus replication
Time frame: 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
Immunoglobulin A (IgA) detection in feces
In case of asymptomatic infection, IgA are secreted
Time frame: within 3-5 days after consumption
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2020; primary completion for Feb 2020, 1 month later.
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This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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