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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
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Christine Moe, PhD, 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.


Condition or disease Intervention/treatment
Healthy Procedure: High Hydrostatic Pressure Processing

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach
Study Start Date : September 2007
Primary Completion Date : October 2009
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Infection with norovirus [ Time Frame: Throughout participation in study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Georgia
Emory University General Clinical Research Center
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Virginia Polytechnic Institute and State University
Investigators
Principal Investigator: Christine Moe, PhD Emory University
Principal Investigator: George M Lyon III, MD, MMSc Emory University

Publications:
Responsible Party: Christine Moe, PhD, Gangarosa Professor, Emory University
ClinicalTrials.gov Identifier: NCT00674336     History of Changes
Other Study ID Numbers: 0551-2006
RSPHGH-CLM-2007-NoVSHELLFISH ( Other Identifier: Other )
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Christine Moe, PhD, Emory University:
Norovirus
Gastroenteritis
Clinical Trial
Stomach flu
Oysters
Shellfish
high hydrostatic pressures