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CompletedNCT00674336ShellfishUpdated Nov 19, 2013

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

An interventional study of High Hydrostatic Pressure Processing in Healthy, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-19.

Sponsored by Emory University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
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Study 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.

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Conditions studied

  • Healthy

Keywords

  • Norovirus
  • Gastroenteritis
  • Clinical Trial
  • Stomach flu
  • Oysters
  • Shellfish
  • high hydrostatic pressures
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In context

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Normal healthy volunteer
  • Age must be between 18 and 50 years of age

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Shellfish with Norovirus

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

    Procedure: High Hydrostatic Pressure Processing

Interventions

  • ProcedureHigh 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.

    Also known as: HPP

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What researchers measure

Primary outcomes

  1. Infection with norovirus

    Time frame: Throughout participation in study

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Study locations

1 site
  • Emory University General Clinical Research Center
    Atlanta, Georgia 30322, United States
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References and documents

Publications

  • 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. PubMed 21705552 ↗
  • 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. PubMed 31504095 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00674336
Lead sponsor
Emory University
Collaborators
Virginia Polytechnic Institute and State University
Responsible party
Christine Moe, PhD (Gangarosa Professor, Emory University) — Principal investigator
First posted
May 7, 2008
Start date
Sep 2007
Primary completion
Oct 2009
Completion
Mar 2010
Last update
Nov 19, 2013

Study contacts

Christine Moe, PhD
principal investigator · Emory University
George M Lyon III, MD, MMSc
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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