Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-27 @ 1:29 AM
Study NCT ID:
NCT05603650
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2022-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'White tape over receptacle'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total bacterial load and mRNA analysis', 'timeFrame': 'Day 0', 'description': 'total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR'}, {'measure': 'total bacterial load and mRNA analysis', 'timeFrame': 'Day 30', 'description': 'total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR'}, {'measure': 'total bacterial load and mRNA analysis', 'timeFrame': 'Day 60', 'description': 'total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR'}, {'measure': 'total bacterial load and mRNA analysis', 'timeFrame': 'Day 90', 'description': 'total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR'}, {'measure': 'total bacterial load and mRNA analysis', 'timeFrame': 'Day 180', 'description': 'total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR'}, {'measure': 'viral load and mRNA analysis using RT-PCR', 'timeFrame': 'Day 0', 'description': 'viral load: HSV1, CMV, EBV'}, {'measure': 'viral load and mRNA analysis using RT-PCR', 'timeFrame': 'Day 30', 'description': 'viral load: HSV1, CMV, EBV'}, {'measure': 'viral load and mRNA analysis using RT-PCR', 'timeFrame': 'Day 60', 'description': 'viral load: HSV1, CMV, EBV'}, {'measure': 'viral load and mRNA analysis using RT-PCR', 'timeFrame': 'Day 90', 'description': 'viral load: HSV1, CMV, EBV'}, {'measure': 'viral load and mRNA analysis using RT-PCR', 'timeFrame': 'Day 180', 'description': 'viral load: HSV1, CMV, EBV'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Microbiome', 'Fecal Microbiome'], 'conditions': ['Oral Bacterial Infection', 'Oral Infection', 'Microbial Colonization', 'Viral Infection']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. The participant will be randomly allocated to rinse their mouth twice daily either with Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water. The overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit.", 'detailedDescription': 'Goal of this pilot study is to identify the effects of 2 over-the-counter mouthrinses on the microbiome of the oral cavity and the GI tract. We will investigate 2 mouthwashes, plus an additional non-treatment group (water rinse only). One mouthwash has antimicrobial activity (ListerineR, Johnson \\& Johnson Consumer Healthcare Products, Skillman, New Jersey); the other targets microbial products only (Lumineux Oral Essentials Clean and Fresh MouthwashR, Los Angeles, CA). Oral plaque will be collected with a sterile swab using a commercial collection kit on Day 0, Day 30, Day 60, Day 90, and Day 180 of the study. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit. Subjects will rinse 2x daily for approximately 180 days using either mouthwash or water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Eligible men and non-pregnant and non-lactating women of all races age 18-25.\n* Volunteers must consent to participate in all scheduled exam visits and procedures.\n* Volunteers must be available for follow up on the telephone.\n* Healthy gums or gums that bleed when you brush them.\n\nExclusion Criteria:\n\n* Volunteers unable or unwilling to sign the informed consent form.\n* Less than 20 teeth (excluding third molars).\n* Individuals who have taken antibiotics in the previous 3 months.\n* Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data."}, 'identificationModule': {'nctId': 'NCT05603650', 'acronym': 'Microbiome', 'briefTitle': 'Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract', 'orgStudyIdInfo': {'id': '20205719'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Water rinse', 'description': 'rinse twice daily for 1 min with water', 'interventionNames': ['Other: Lumineux Oral Essentials rinse', 'Other: Listerine rinse']}, {'type': 'EXPERIMENTAL', 'label': 'Lumineux Oral Essentials rinse', 'description': 'rinse twice daily for 1 min with Lumineux Oral Essentials rinse', 'interventionNames': ['Other: Listerine rinse']}, {'type': 'EXPERIMENTAL', 'label': 'Listerine rinse', 'description': 'rinse twice daily for 1 min with Listerine rinse', 'interventionNames': ['Other: Lumineux Oral Essentials rinse']}], 'interventions': [{'name': 'Lumineux Oral Essentials rinse', 'type': 'OTHER', 'description': 'mouthrinse', 'armGroupLabels': ['Listerine rinse', 'Water rinse']}, {'name': 'Listerine rinse', 'type': 'OTHER', 'description': 'mouthrinse', 'armGroupLabels': ['Lumineux Oral Essentials rinse', 'Water rinse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Wakida, PhD', 'role': 'CONTACT', 'email': 'nwakida@uci.edu', 'phone': '949-824-4360'}, {'name': 'Petra Wilder-Smith, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beckman Laser Institute and Medical Clinic', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'centralContacts': [{'name': 'Nicole Wakida, PhD', 'role': 'CONTACT', 'email': 'nwakida@uci.edu', 'phone': '949-824-4360'}], 'overallOfficials': [{'name': 'Petra Wilder-Smith, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calfornia Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery and Director of Dentistry', 'investigatorFullName': 'Petra E. Wilder-Smith', 'investigatorAffiliation': 'University of California, Irvine'}}}}