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Completed

NCT Number: NCT00313404

Infectivity of Norovirus in Groundwater-Human Challenge Study

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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Key information

Conditions

Healthy Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University General Clinical Research Center

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Safety tested norovirus inoculum

Biological

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

Other names: Norwalk virus in groundwater

Primary outcomes

  1. Infection with norovirus

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study title

Assessment of Calicivirus Survival in Surface Water and Subsurface Water

Important dates

Study start
2006
Primary completion
2007
Study completion
2011
First posted
Apr 12, 2006
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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