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CompletedNCT00313404Updated Nov 19, 2013

Infectivity of Norovirus in Groundwater-Human Challenge Study

An interventional study of Safety tested norovirus inoculum 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
13
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 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.

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Conditions studied

  • Healthy

Keywords

  • Norovirus
  • Gastroenteritis
  • Clinical Trial
  • Stomach flu
03

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
  • Must be within 33% of normal body mass index

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Norovirus in groundwater

    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

  • BiologicalSafety tested norovirus inoculum

    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

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What researchers measure

Primary outcomes

  1. Infection with norovirus

    Time frame: Throughout study

07

Study locations

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

Publications

  • 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. PubMed 21856841 ↗
  • 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
NCT00313404
Lead sponsor
Emory University
Collaborators
Johns Hopkins University
Responsible party
Christine Moe, PhD (Gangarosa Professor, Emory University) — Principal investigator
First posted
Apr 12, 2006
Start date
Feb 2006
Primary completion
Jan 2007
Completion
Apr 2011
Last update
Nov 19, 2013

Study contacts

Christine Moe, PhD
principal investigator · Emory University
George M Lyon III, MD, MMSc
principal investigator · Emory University
Kellogg Schwab, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
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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