Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT06883760
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Study on Probiotic Combination Tableted Candy Hangover
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline blood alcohol during alcohol test at 1 month', 'timeFrame': 'Baseline (Day 0), Intervention end point (Day 28)', 'description': 'Determination of the change of blood alcohol of the participants during alcohol test at 1 months.'}], 'secondaryOutcomes': [{'measure': 'Changes in serum acetaldehyde during alcohol test at 1 month', 'timeFrame': 'Baseline (Day 0), Intervention end point (Day 28)', 'description': 'Determination of the changes of serum acetaldehyde during alcohol test at 1 month'}, {'measure': 'Changes of saliva acetaldehyde during alcohol test from baseline at 1 month', 'timeFrame': 'Baseline (Day 0), Intervention end point (Day 28)', 'description': 'Determination of the changes of saliva acetaldehyde during alcohol test from baseline at 1 month'}, {'measure': 'Change from baseline fecal microbiota at 1 month', 'timeFrame': 'Baseline (Day 0), Intervention end point (Day 28)', 'description': 'Determination of the change from baseline fecal microbiota at 1 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['probiotics', 'medicine and food homologous substances', 'bioactive peptides', 'alcohol consumption'], 'conditions': ['Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking', 'The Potential of the Probiotics Combination Tablet on Alcohol Metabolism']}, 'descriptionModule': {'briefSummary': 'Study Design Type: Randomized, blinded, placebo-controlled, crossover trial Participants: 40 volunteers, divided into two groups (n=20) Grouping Method: Minimization randomization based on age and BMI matching\n\nIntervention Sequence:\n\nGroup A: Probiotic intervention → washout → placebo intervention Group B: Placebo intervention → washout → probiotic intervention Blinding: Participants, data collectors, and data analysts were blinded Roles: Randomization, data collection, and data analysis were performed by different researchers\n\nIntervention Process\n\nPhase 1 (Week 1):\n\nGroup A: Took probiotic tablets (1g twice daily, 0.5g/tablet) Group B: Took placebo tablets (1g twice daily, 0.5g/tablet) Washout Period: 2 weeks\n\nPhase 2 (Week 4):\n\nGroup A: Took placebo tablets Group B: Took probiotic tablets\n\nSample Collection\n\nFecal Samples: Collected at three time points:\n\nBaseline (1 week before alcohol test) Day 7 (after Phase 1) Day 28 (after Phase 2) Alcohol Tests: Conducted on Day 7 and Day 28 after overnight fasting Body Weight: Measured on test days; alcohol dosage adjusted accordingly (1 mL/kg, 40% v/v) Serum and Saliva: Collected at multiple time points post-alcohol consumption', 'detailedDescription': 'A randomized, blinded, placebo-controlled, crossover trial was conducted. Forty participants were divided into two groups (n=20). Then, for each block, randomization was performed by minimization by matching age and body mass index (BMI). The two groups received different sequences of Probiotic combination intervention and maltodextrin intervention (placebo), coded as A and B to conceal their identities. Participants, data collectors, and data analysts were blinded throughout the study. Different researchers performed randomization, data collection, and data analysis.\n\nThe 40 volunteers recruited were randomly divided into two groups (n=20) after signing the informed consent form, namely the Probiotic combination intervention group (Group A, probiotic intake → flushing → placebo intake) and the maltodextrin (placebo) group (Group B, placebo intake → flushing → probiotic intake). Group A tried the compressed tablet product for 1 week, and Group B tried the placebo for 1 week; after a 2-week washout period, Group A tried the placebo for 1 week, and Group B tried the compressed tablet product for 1 week. During the intervention period, volunteers took 1g of the compressed tablets twice a day (0.5g/tablet, 2 tablets) in the morning, noon and evening, and during the intervention period, volunteers took 1g of the placebo twice a day (0.5g/tablet, 2 tablets) in the morning and evening. Feces of all volunteers were collected one week before the alcohol experiment (first time), and the second and third feces were collected on the 7th and 28th days, respectively. Alcohol tests were performed on the 7th and 28th days after an overnight fast. Body weight was measured on the test day, and liquor was provided according to body weight. Participants ate a meal (standard diet) containing alcohol (alcohol content: 40% v/v, 1 mL/kg body weight), and serum and saliva of volunteers were collected at different time points after the meal. During the intervention period, all subjects followed their original dietary habits and stopped taking other alcohol-detoxifying and liver-protecting drugs or drugs that may affect alcohol metabolism. The medication method during the alcohol test was: 2 pills before the alcohol tolerance test after lunch (the first time point); 2 pills before drinking (i.e., before the hangover test at two time points); and 2 pills after waking up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-60 years old\n* BMI: 18-25 kg/m2\n* Healthy adults with experience of being drunk, fully understanding the experimental plan, and voluntarily agreeing to participate\n* Able to tolerate a certain amount of alcohol (calculated as 60 kg, about 60 mL of 40-proof liquor)\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* People who are very intolerant to alcohol, with aldehyde dehydrogenase activity of 2%\n* People with a history of allergic reactions or clinical allergic reactions to drugs, alcohol, products or other ingredients\n* People who have taken drugs that induce and inhibit drug metabolizing enzymes, such as barbiturates, within one month from the date of the screening test\n* People who have taken drugs that affect the results of clinical trials (alcohol metabolism) (aspirin, antipyretics, anti-inflammatory drugs, analgesics, antibiotics, herbal medicines, oral steroids, hormones, etc.) within 1 month from the screening population\n* People who have taken drugs, products and functional foods that affect the intestines (such as probiotics, yogurt, etc.) within 10 days before the test\n* People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test\n* People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test. Those who have taken products that affect the test results, such as products or drugs that relieve alcohol, etc.\n* Those who suffer from severe acute or chronic diseases such as cardiovascular disease, metabolic disease, hepatobiliary disease, pancreatic disease, muscle disease, nervous system disease, mental disorder, endocrine disease, immune disease, kidney disease, malignant tumor, lung disease and other diseases that require treatment\n* Those who have received or are receiving clinically significant treatment for gastrointestinal diseases such as gastric or duodenal ulcers\n* Those who have donated blood within 2 months from the date of screening\n* Those whose serum AST, ALT or creatine kinase levels are higher than the reference range or twice the serum upper limit, and the creatinine level in the diagnostic test exceeds 2.0 mg/dL\n* Those who are considered unsuitable due to diagnostic test results or other reasons.'}, 'identificationModule': {'nctId': 'NCT06883760', 'briefTitle': 'Intervention Study on Probiotic Combination Tableted Candy Hangover', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Intervention Study on Probiotic Composite Compressed Candy Tablets for Alleviation of Alcohol-Induced Symptoms', 'orgStudyIdInfo': {'id': 'LL2023-X27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Combination Product: Probiotic tablet candy group']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic tablet candy', 'interventionNames': ['Combination Product: Probiotic tablet candy group']}], 'interventions': [{'name': 'Probiotic tablet candy group', 'type': 'COMBINATION_PRODUCT', 'description': '40 volunteers were randomly divided into two groups (n=20): Group A (probiotic → washout → placebo) and Group B (placebo → washout → probiotic). Each group took 1g of tablets (0.5g/tablet, 2 tablets) twice daily for 1 week, followed by a 2-week washout, then switched interventions. Fecal samples were collected at baseline, Day 7, and Day 28. Alcohol tests were conducted on Days 7 and 28 after fasting; participants consumed alcohol (1 mL/kg, 40% v/v) with a standard meal. Serum and saliva were collected post-meal. Body weight was measured, and alcohol dosage was adjusted accordingly. Participants maintained their usual diet and avoided alcohol-detoxifying or liver-protecting drugs. Medication during alcohol tests: 2 pills before tolerance test (after lunch), 2 pills before drinking, and 2 pills after waking.', 'armGroupLabels': ['Placebo', 'Probiotic tablet candy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '313200', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'ZJUT(Zhejiang University of Technology)', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Privacy and Ethical Concerns: IPD often contains sensitive personal information, and sharing it may violate privacy protection regulations or the requirements of ethical review boards, especially if the data is not fully de-identified.\n\nData Ownership and Control: The research team may retain ownership of the data and wish to maintain control over its use to ensure it is utilized in alignment with the original research objectives.\n\nIntellectual Property and Commercial Interests: Certain research may involve potential commercial value or intellectual property, and sharing IPD could impact future patent applications or commercialization efforts.\n\nResource Constraints: Preparing and sharing IPD in a usable and compliant format can be time-consuming and resource-intensive, which may not be feasible for the research team.\n\nRisk of Misinterpretation: Shared data might be misinterpreted or misused by others, potentially leading to incorrect conclusions or misuse of the findings.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Fengqin Feng', 'investigatorAffiliation': 'Zhejiang University'}}}}