NCT00313404

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 see how long Norwalk virus can survive in water and still be able to cause sickness. When this is determined the researchers will be able to recommend risk levels for norovirus contaminated waters. Another purpose for this study is to see how a person's body's immune cells respond to Norwalk virus in the body. During this study volunteers will receive a dose of Norwalk virus in water that may make them sick.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

April 10, 2006

Last Update Submit

November 18, 2013

Conditions

Healthy

Keywords

NorovirusGastroenteritisClinical TrialStomach flu

Outcome Measures

Primary Outcomes (1)

  • Infection with norovirus

    Throughout study

Study Arms (1)

Norovirus in groundwater

EXPERIMENTAL

We dosed volunteers with safety tested infectious norovirus in groundwater (that met EPA standards for drinking water). The length of time norovirus remained in groundwater varied by volunteer.

Biological: Safety tested norovirus inoculum

Interventions

Safety tested norovirus inoculumBIOLOGICAL

This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards

Also known as: Norwalk virus in groundwater
Norovirus in groundwater

Eligibility Criteria

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

You may qualify if:

  • Normal healthy volunteer
  • Must be within 33% of normal body mass index

You may not qualify if:

  • Have a job in which they handle food
  • Work in a child care, elderly care center or if they live with young children or anyone who has a weak immune system
  • Are not willing or able to wash their hands every time after they go to the bathroom, or before and after they prepare or handle food for up to eight days after they take the virus
  • Are over the age of 50
  • Are pregnant
  • Have tested positive for the HIV virus

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)

  • Seitz SR, Leon JS, Schwab KJ, Lyon GM, Dowd M, McDaniels M, Abdulhafid G, Fernandez ML, Lindesmith LC, Baric RS, Moe CL. Norovirus infectivity in humans and persistence in water. Appl Environ Microbiol. 2011 Oct;77(19):6884-8. doi: 10.1128/AEM.05806-11. Epub 2011 Aug 19.

    PMID: 21856841RESULT

  • 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

Interventions

Groundwater

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Geological PhenomenaPhysical Phenomena

Study Officials

  • Christine Moe, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

  • George M Lyon III, MD, MMSc

    Emory University

    PRINCIPAL INVESTIGATOR

  • Kellogg Schwab, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

February 1, 2006

Primary Completion

January 1, 2007

Study Completion

April 1, 2011

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

US(1)