Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study (Shellfish)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00674336|
Recruitment Status : Completed
First Posted : May 7, 2008
Last Update Posted : November 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Procedure: High Hydrostatic Pressure Processing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||March 2010|
Experimental: Shellfish with Norovirus
We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus
Procedure: High 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.
Other Name: HPP
- Infection with norovirus [ Time Frame: Throughout participation in study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674336
|United States, Georgia|
|Emory University General Clinical Research Center|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Christine Moe, PhD||Emory University|
|Principal Investigator:||George M Lyon III, MD, MMSc||Emory University|