NCT00674336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

2.1 years

First QC Date

May 6, 2008

Last Update Submit

November 18, 2013

Conditions

Healthy

Keywords

NorovirusGastroenteritisClinical TrialStomach fluOystersShellfishhigh hydrostatic pressures

Outcome Measures

Primary Outcomes (1)

  • Infection with norovirus

    Throughout participation in study

Study Arms (1)

Shellfish with Norovirus

EXPERIMENTAL

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

Procedure: High Hydrostatic Pressure Processing

Interventions

High Hydrostatic Pressure ProcessingPROCEDURE

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
Shellfish with Norovirus

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University General Clinical Research Center

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

  • 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.

    PMID: 21705552RESULT

  • 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.

    PMID: 31504095DERIVED

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Christine Moe, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

  • George M Lyon III, MD, MMSc

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gangarosa Professor

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

September 1, 2007

Primary Completion

October 1, 2009

Study Completion

March 1, 2010

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

US(1)