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

Emory University logo

Emory University

Status

Completed

Conditions

Healthy

Treatments

Procedure: High Hydrostatic Pressure Processing

Study type

Interventional

Funder types

Other

Identifiers

NCT00674336
0551-2006
RSPHGH-CLM-2007-NoVSHELLFISH (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Triple Blind

51 participants in 1 patient group

Shellfish with Norovirus
Experimental group
Description:
We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus
Treatment:
Procedure: High Hydrostatic Pressure Processing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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