Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568380
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2019-09-23
Brief Title:
Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of Norovirus Infection Incidence According to the Presence of Fecal Bacteriophages After Oyster Consumption Randomized Controlled Clinical Trial - VIROYSTER
Status:
WITHDRAWN
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study abandoned before authorization obtained
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIROYSTER
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 doesnt 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None