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

NCT ID: NCT00674336

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-03-31

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.

Conditions

Healthy

Keywords

Norovirus; Gastroenteritis; Clinical Trial; Stomach flu; Oysters; Shellfish; high hydrostatic pressures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Shellfish with Norovirus

We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus

Group Type: EXPERIMENTAL

High Hydrostatic Pressure Processing

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

HPP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Christine Moe, PhD

Gangarosa Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Moe, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

George M Lyon III, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University General Clinical Research Center

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21705552 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31504095 (View on PubMed)

Other Identifiers

RSPHGH-CLM-2007-NoVSHELLFISH

Identifier Type: OTHER

Identifier Source: secondary_id

0551-2006

Identifier Type: -

Identifier Source: org_study_id