Validation of a Boindicator as Monitoring Tool for Oyster Norovirus Outbreak

NCT06568380 | Withdrawn

• 1 other identifier: 2019-A01763-54
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteritis Norovirus

Outcome Measures

Primary Outcomes (3)

• Norovirus concentration in feces (genome copy number/grammes of feces)

  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

  within 3 days after consumption

• Immunoglobulin A (IgA) detection in feces

  In case of asymptomatic infection, IgA are secreted

  within 3-5 days after consumption

Study Arms (4)

Noro+ Phage+

EXPERIMENTAL

Oysters positives for both norovirus genome and infectious bacteriophages

Other: Oyster consumption

Noro+ Phage-

EXPERIMENTAL

Oysters positives for norovirus genome and negatives for infectious bacteriophages

Other: Oyster consumption

Noro- Phage+

EXPERIMENTAL

Oysters negatives for norovirus genome and positives for infectious bacteriophages

Other: Oyster consumption

Noro- Phage-

PLACEBO COMPARATOR

Oysters negatives for both norovirus genome and infectious bacteriophages

Other: Oyster consumption

Interventions

Oyster consumption OTHER

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

Noro+ Phage+; Noro+ Phage-; Noro- Phage+; Noro- Phage-

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent signed
• Health status
• No seafood allergy
• Nancy city residents

You may not qualify if:

• Recent gastroenteritis (\<6 months)
• Fragile health person proximity
• Oysters consumption during the study
• Pregnancy or breastfeeding
• "nonsecretor" phenotype

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, Lorraine, 54000, France

Location

Study Officials

• Christophe Gantzer, Pr

  LCPME -UMR Université de Lorraine/CNRS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: August 23, 2024
• Study Start: January 1, 2020
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

FR (1)