Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 4:40 AM
Study NCT ID:
NCT01583803
Status:
UNKNOWN
Last Update Posted:
2016-12-21
First Post:
2012-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex Differences in Oral Bacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-05-15', 'releaseDate': '2020-05-03'}, {'resetDate': '2025-06-25', 'releaseDate': '2025-06-06'}], 'estimatedResultsFirstSubmitDate': '2020-05-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine, saliva and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2012-04-20', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial species identification', 'timeFrame': 'At baseline'}], 'secondaryOutcomes': [{'measure': 'Bacterial count', 'timeFrame': 'At baseline'}, {'measure': 'Blood pressure', 'timeFrame': 'At baseline'}, {'measure': 'Nitrogen oxide levels in biological fluids', 'timeFrame': 'At baseline'}, {'measure': 'Oral nitrate reduction', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '20585108', 'type': 'BACKGROUND', 'citation': 'Kapil V, Milsom AB, Okorie M, Maleki-Toyserkani S, Akram F, Rehman F, Arghandawi S, Pearl V, Benjamin N, Loukogeorgakis S, Macallister R, Hobbs AJ, Webb AJ, Ahluwalia A. Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO. Hypertension. 2010 Aug;56(2):274-81. doi: 10.1161/HYPERTENSIONAHA.110.153536. Epub 2010 Jun 28.'}, {'pmid': '30031863', 'type': 'DERIVED', 'citation': 'Kapil V, Rathod KS, Khambata RS, Bahra M, Velmurugan S, Purba A, S Watson D, Barnes MR, Wade WG, Ahluwalia A. Sex differences in the nitrate-nitrite-NO* pathway: Role of oral nitrate-reducing bacteria. Free Radic Biol Med. 2018 Oct;126:113-121. doi: 10.1016/j.freeradbiomed.2018.07.010. Epub 2018 Jul 20.'}]}, 'descriptionModule': {'briefSummary': 'Females have a lower incidence of hypertensive and cardiovascular disorders that may relate to differences in nitrogen oxides in the blood and saliva. Some nitrogen oxides are recycled with the help of oral bacteria to nitric oxide which is protective against vascular disorders. This study will test the hypothesis that females have different numbers and species of these nitrogen-oxide reducing bacteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form\n\nExclusion Criteria:\n\n1. Healthy subjects unwilling to consent\n2. History of hypertension, diabetes or hypertensive on BP measurement\n3. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result\n4. History of any serious illnesses, including recent infections or trauma\n5. Subjects taking systemic medication (other than the oral contraceptive pill)\n6. Subjects with self-reported use of mouthwash or tongue scrapes\n7. Subjects with recent or current antibiotic use (within 3 months)\n8. Subjects with a history, or recent treatment of (within last 3 months) of any oral condition (excluding caries), including gingivitis, periodontitis and halitosis'}, 'identificationModule': {'nctId': 'NCT01583803', 'briefTitle': 'Sex Differences in Oral Bacteria', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Investigation of the Sex Differences in Oral Microbiota and Their Effect on Circulating Nitrite Levels', 'orgStudyIdInfo': {'id': '12/LO/0108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Males'}, {'label': 'Females'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1M 6BQ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'William Harvey Heart Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Amrita Ahluwalia, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary University London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Vascular Pharmacology', 'investigatorFullName': 'Amrita Ahluwalia', 'investigatorAffiliation': 'Queen Mary University of London'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-05-03', 'type': 'RELEASE'}, {'date': '2020-05-15', 'type': 'RESET'}, {'date': '2025-06-06', 'type': 'RELEASE'}, {'date': '2025-06-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Queen Mary University of London'}}}}