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

Emory University51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Emory University General Clinical Research Center

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Infection with norovirus

Time frame: Throughout participation in study

Data from ClinicalTrials.gov

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