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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Procedure: High Hydrostatic Pressure Processing

• Registration Number: NCT00674336
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2009-10
• Study Completion: 2010-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shellfish with Norovirus	High Hydrostatic Pressure Processing	We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus

Primary Outcome Measures

Name	Time	Method
Infection with norovirus	Throughout participation in study

Trial Locations

Locations (1)

Emory University General Clinical Research Center; 🇺🇸 Atlanta, Georgia, United States