Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
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Purpose
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 | Intervention |
|---|---|
|
Healthy |
Procedure: High Hydrostatic Pressure Processing |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach |
- Infection with norovirus [ Time Frame: Throughout participation in study ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | Christine Moe, PhD, Gangarosa Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT00674336 History of Changes |
| Other Study ID Numbers: | RSPHGH-CLM-2007-NoVSHELLFISH |
| Study First Received: | May 6, 2008 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Norovirus Gastroenteritis Clinical Trial Stomach flu |
Oysters Shellfish high hydrostatic pressures |
ClinicalTrials.gov processed this record on June 17, 2013