Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT00313404
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2006-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Infectivity of Norovirus in Groundwater-Human Challenge Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D060587', 'term': 'Groundwater'}], 'ancestors': [{'id': 'D055593', 'term': 'Geological Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2006-04-10', 'studyFirstSubmitQcDate': '2006-04-10', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection with norovirus', 'timeFrame': 'Throughout study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Norovirus', 'Gastroenteritis', 'Clinical Trial', 'Stomach flu'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '21856841', 'type': 'RESULT', 'citation': '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': '31504095', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal healthy volunteer\n* Must be within 33% of normal body mass index\n\nExclusion Criteria:\n\n* Have a job in which they handle food\n* Work in a child care, elderly care center or if they live with young children or anyone who has a weak immune system\n* 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\n* Are over the age of 50\n* Are pregnant\n* Have tested positive for the HIV virus'}, 'identificationModule': {'nctId': 'NCT00313404', 'briefTitle': 'Infectivity of Norovirus in Groundwater-Human Challenge Study', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Assessment of Calicivirus Survival in Surface Water and Subsurface Water', 'orgStudyIdInfo': {'id': '0584-2002'}, 'secondaryIdInfos': [{'id': 'EPA-5 R01 AI056351-03', 'type': 'OTHER', 'domain': 'Emory University Clinical Trials Office'}, {'id': '82911601-1', 'type': 'OTHER_GRANT', 'domain': 'Environmental Protection Agency'}, {'id': 'RSPHGH-CLM-2005-EPANoV', 'type': 'OTHER', 'domain': 'Other'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Norovirus in groundwater', 'description': '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.', 'interventionNames': ['Biological: Safety tested norovirus inoculum']}], 'interventions': [{'name': 'Safety tested norovirus inoculum', 'type': 'BIOLOGICAL', 'otherNames': ['Norwalk virus in groundwater'], 'description': 'This is a safety tested live infectious norovirus inoculum that has been placed in groundwater that meets EPA drinking water standards', 'armGroupLabels': ['Norovirus in groundwater']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University General Clinical Research Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Christine Moe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'George M Lyon III, MD, MMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Kellogg Schwab, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gangarosa Professor', 'investigatorFullName': 'Christine Moe, PhD', 'investigatorAffiliation': 'Emory University'}}}}