Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-03-13 @ 3:57 AM
Study NCT ID:
NCT04457661
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath Alcohol Level', 'timeFrame': '5 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}, {'measure': 'Breath Alcohol Level', 'timeFrame': '15 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}, {'measure': 'Breath Alcohol Level', 'timeFrame': '30 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}, {'measure': 'Breath Alcohol Level', 'timeFrame': '60 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}, {'measure': 'Breath Alcohol Level', 'timeFrame': '90 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}, {'measure': 'Breath Alcohol Level', 'timeFrame': '120 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}, {'measure': 'Breath Alcohol Level', 'timeFrame': '150 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}, {'measure': 'Breath Alcohol Level', 'timeFrame': '180 minutes after drinking a certain volume of whisky', 'description': 'A breathalyzer will be used for estimating blood alcohol content (BAC) from a breath sample.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breath Alcohol Level']}, 'descriptionModule': {'briefSummary': 'Investigating the possibility of using Bacillus coagulans TCI711 to improve the efficiency of alcohol removal in adult individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers aged between 20 to 60.\n* Systolic pressure below 140\n* Score of C-CAGE Questionnaire below 8 (male)/6 (female)\n* Prohibiting other supplements before 2 weeks of the study and during the study\n* Prohibiting alcohol drinks before 24 hours of the study\n* Prohibiting caffeine drinks before 12 hours of the study\n\nExclusion Criteria:\n\n* Alcohol or drug allergy\n* Liver, kidney, cardiovascular, or chronic diseases\n* Other severe disorders\n* Hypertension\n* Pregnancy or lactation\n* Already involved in clinical testing\n* Other supplements'}, 'identificationModule': {'nctId': 'NCT04457661', 'acronym': 'TCI711', 'briefTitle': 'Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals', 'organization': {'class': 'INDUSTRY', 'fullName': 'TCI Co., Ltd.'}, 'officialTitle': 'Evaluation of the Alcohol Elimination Effect of TCI711 Probiotic (Bacillus Coagulans) on Adult Individuals', 'orgStudyIdInfo': {'id': '20-036-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCI711 probiotic', 'description': 'Taking one capsule (containing 10\\^10 of Bacillus coagulans TCI711) daily for one month', 'interventionNames': ['Dietary Supplement: Bacillus coagulans TCI711']}], 'interventions': [{'name': 'Bacillus coagulans TCI711', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.', 'armGroupLabels': ['TCI711 probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'GeNext', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}