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Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study

Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00674336
Acronym
Shellfish
Enrollment
51
Registered
2008-05-07
Start date
2007-09-30
Completion date
2010-03-31
Last updated
2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Norovirus, Gastroenteritis, Clinical Trial, Stomach flu, Oysters, Shellfish, high hydrostatic pressures

Brief summary

Norwalk virus and related Norwalk-like viruses are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States. These viruses are sometimes found in drinking water, ice, shellfish and in other foods. They can be spread easily from contact with water, food, objects or hands that have even small amounts of feces from someone who was sick. The purpose of this research study is to the effectiveness of high hydrostatic pressures processing (HPP) treatment on norovirus infected shellfish. Norwalk virus can survive in shellfish and still be able to cause sickness. HPP inactivates microorganisms living both on the surface and on the interior of the food. The goal of the study is to determine whether HPP treatment on oysters spiked with norovirus will reduce infection rates in people consuming raw infected oysters.

Interventions

PROCEDUREHigh Hydrostatic Pressure Processing

High Hydrostatic Pressure Processing is a technology, used in the food service industry, where foods are subjected to high pressure. These high pressures kill many pathogens without affecting the quality of the food.

Sponsors

Virginia Polytechnic Institute and State University
CollaboratorOTHER
Emory University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Normal healthy volunteer * Age must be between 18 and 50 years of age

Exclusion criteria

* Have a job in which you handle food * Are a health care worker with direct patient contact * Work in a child care, elderly care center or if you live with young children or anyone who has a weak immune system * Are not willing or able to wash your hands every time after you go to the bathroom, or before and after you prepare or handle food throughout the whole study * Are anemic * Are not willing to give us permission to store and use your data and samples

Design outcomes

Primary

MeasureTime frame
Infection with norovirusThroughout participation in study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026