Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06899620
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BC179 Relieves Discomfort After Drinking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004327', 'term': 'Drinking Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of BC179 on alcohol metabolism', 'timeFrame': '60 days', 'description': 'The impact of BC179 on alcohol metabolism is assessed by monitoring blood alcohol concentration (BAC) and related enzyme activities, such as alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drinking Behavior']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness and safety of probiotic strain BC179 in reducing alcohol absorption in the gut, thereby lowering health risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria:\n\n 1. Participants must be aged between 18 and 65 years.\n 2. They should have a documented history of long-term alcohol consumption, defined as consuming at least 20 grams of ethanol per day for at least one year. This is calculated using the formula: volume (mL) × alcohol content (%) × 0.8.\n 3. They must provide written informed consent and be willing to comply with the study procedures.\n* Exclusion Criteria:\n\n 1. History of chronic liver, gastrointestinal, or systemic metabolic disorders.\n 2. Use of products with similar functions to the investigational formulation within the past two weeks.\n 3. Use of antibiotics, laxatives, or dietary supplements within the past four weeks.\n 4. Documented history of hypertension or diabetes.\n 5. Severe allergies or immune deficiencies.\n 6. Pregnancy, lactation, or planning pregnancy without effective contraception during the study period.'}, 'identificationModule': {'nctId': 'NCT06899620', 'briefTitle': 'BC179 Relieves Discomfort After Drinking', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'Weizmannia Coagulans BC179 Alleviates Post-Alcohol Discomfort May Via Taurine-Related Metabolism and Antioxidant Regulation: A Randomized, Double-Blind，Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'WK20250323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': '10B CFU/Sachet/Day BC179 ; Storage: Store in cool and dry place without sun exposure', 'interventionNames': ['Dietary Supplement: Probiotic group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Dextrin one Sachet/Day; Storage: Store in cool and dry place without sun exposure', 'interventionNames': ['Dietary Supplement: Placebo group']}], 'interventions': [{'name': 'Probiotic group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study lasted for 60 days.', 'armGroupLabels': ['Probiotic group']}, {'name': 'Placebo group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study lasted for 60 days.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471000', 'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'facility': 'Wu Ying', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}