HealthyShellfishNCT00674336
Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
A study testing High Hydrostatic Pressure Processing in people with Healthy, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High Hydrostatic Pressure Processing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteer
- Age must be between 18 and 50 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University General Clinical Research Center
Atlanta, Georgia, 30322
About this study
Official title: Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach
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.
- Conditions
- Healthy
- Being tested
- High Hydrostatic Pressure Processing
- Keywords
- Norovirus, Gastroenteritis, Clinical Trial, Stomach flu, Oysters, Shellfish, high hydrostatic pressures
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Hydrostatic Pressure ProcessingProcedure or surgery
Also called HPP
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.
| Study group | Role | What they receive |
|---|---|---|
| Shellfish with Norovirus | Experimental | We dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus Receives: Procedure: High Hydrostatic Pressure Processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection with norovirus
Measured: Throughout participation in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Christine Moe, PhD, Emory University
- Investigators
- Christine Moe, PhD, Principal investigator, Emory UniversityGeorge M Lyon III, MD, MMSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674336
- Sponsor's protocol ID
- 0551-2006
- Other IDs
- RSPHGH-CLM-2007-NoVSHELLFISH
- Acronym
- Shellfish
- Status last verified
- Nov 2013
- First submitted
- 6 May 2008
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 21705552Williams 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwalk Virus Inactivation by High Hydrostatic Pressure Processing: A Comprehensive and Integrated Program for Research and Outreach
- ClinicalTrials.gov ID
- NCT00674336
- Acronym / sponsor ID
- Shellfish / 0551-2006
- Conditions
- Healthy
- Keywords
- Norovirus, Gastroenteritis, Clinical Trial, Stomach flu, Oysters, Shellfish, high hydrostatic pressures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- Sep 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shellfish with Norovirus | Experimental | Procedure: High Hydrostatic Pressure ProcessingWe dosed shellfish with Norovirus and challenged human volunteers with Shellfish that had norovirus |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal healthy volunteer
- Age must be between 18 and 50 years of age
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Hydrostatic Pressure ProcessingAlso: HPPHigh 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. | Procedure or surgery | Shellfish with Norovirus |
Primary outcome
Infection with norovirus
Time frame: Throughout participation in study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Results publication: PubMed 21705552Leon 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.
- Derived from this study: PubMed 31504095Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Moe, PhD principal investigator
Emory University
George M Lyon III, MD, MMSc principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Hydrostatic Pressure Processing in people with Healthy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection with norovirus (time frame: Throughout participation in study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674336, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.