Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-03 @ 3:13 PM
Study NCT ID:
NCT02011035
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2013-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Clinical Efficacy and Safety of Colflex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D006209', 'term': 'Halitosis'}, {'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect on plasma lipid profile and enzyme measurements', 'timeFrame': '30 days', 'description': 'Exploratory efficacy measures include lipid profile, (TC, HDL, TG), and liver enzymes'}, {'measure': 'Measurement of oral halitosis', 'timeFrame': '30 days', 'description': 'A breath sample is taken to measure volatile sulphur compounds using a halimeter.'}], 'primaryOutcomes': [{'measure': 'Frequency and duration of colds/sore throats', 'timeFrame': '30 days', 'description': 'Using a self-reported scale to assess the frequency and during of colds and sore throats at screening, and at baseline and endpoint of treatments'}], 'secondaryOutcomes': [{'measure': 'Assessment of oral pathogenic bacteria', 'timeFrame': '30 days', 'description': 'A mouth swab will be taken to measure pathogenic bacteria (Straph, Strep), and a mouth swab will be used for the BANA test to test for periodontal disease causing bacteria.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oral health', 'Mouth health', 'Halitosis', 'Oral bacteria', 'Sore throat', 'Colds'], 'conditions': ['Personal Satisfaction']}, 'descriptionModule': {'briefSummary': 'This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents in town', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* availability to give written consent\n* age 18-60, men and women (who are not pregnant or nursing)\n* people in good health\n* able to follow protocol\n* must be experiencing a sore throat or cold at least once a year\n\nExclusion Criteria:\n\n* smokers\n* liver and kidney disease\n* inflammatory bowel disease\n* pancreatitis\n* gallbladder or biliary disease\n* neurolgical/psychological disease\n* bleeding disorders\n* platelet abnormatilies\n* gastrointestinal disorders that could interfere with fat absorption\n* serum triglycerides \\> 500 mg/dL and/or total cholesterol \\> 300 mg/dL\n* hypertension (systolic blood pressure \\>160 mm Hg or diastolic blood pressure \\> 100 Hg\n* BMI \\>30\n* consume or planned to consume anticoagulant, hypertension, or lipid lowering medications\n* reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence\n* reported use of experimental medication within 1 month prior to the trial'}, 'identificationModule': {'nctId': 'NCT02011035', 'briefTitle': 'Evaluating the Clinical Efficacy and Safety of Colflex', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Evaluating the Clinical Efficacy and Safety of Colfelx', 'orgStudyIdInfo': {'id': 'B2013:133'}}, 'contactsLocationsModule': {'locations': [{'zip': 'R3T2N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'RCFFN: University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Richardson Centre for Functional Foods and Nutraceuticals', 'investigatorFullName': 'Dr. Peter Jones', 'investigatorAffiliation': 'University of Manitoba'}}}}