Clinical trial NCT00674336: Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
Official title: Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Norovirus
Gastroenteritis
Clinical Trial
Stomach flu
Oysters
Shellfish
high hydrostatic pressures
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2008-05-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Infection with norovirus
timeFrame: Throughout participation in study
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University General Clinical Research Center
state: Georgia
Study officials:
affiliation: Emory University
name: Christine Moe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: George M Lyon III, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leon JS, Kingsley DH, Montes JS, Richards GP, Lyon GM, Abdulhafid GM, Seitz SR, Fernandez ML, Teunis PF, Flick GJ, Moe CL. Randomized, double-blinded clinical trial for human norovirus inactivation in oysters by high hydrostatic pressure processing. Appl Environ Microbiol. 2011 Aug;77(15):5476-82. doi: 10.1128/AEM.02801-10. Epub 2011 Jun 24.
citation: Williams AM, Ladva CN, Leon JS, Lopman BA, Tangpricha V, Whitehead RD, Armitage AE, Wray K, Morovat A, Pasricha SR, Thurnham D, Tanumihardjo SA, Shahab-Ferdows S, Allen L, Flores-Ayala RC, Suchdev PS. Changes in micronutrient and inflammation serum biomarker concentrations after a norovirus human challenge. Am J Clin Nutr. 2019 Dec 1;110(6):1456-1464. doi: 10.1093/ajcn/nqz201.