Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 1:51 PM
Study NCT ID:
NCT06196892
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2023-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics Improve Health Young Volunteers' Gut Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2023-12-24', 'studyFirstSubmitQcDate': '2023-12-24', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in intestinal flora', 'timeFrame': '8 weeks', 'description': 'Collect patient fecal samples, test for 16S rRNA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Diseases']}, 'referencesModule': {'references': [{'pmid': '40652782', 'type': 'DERIVED', 'citation': 'Dong Y, Cai Y, Tian H, Wen J, Han M, Tan Y, Zou K. The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study. Clin Nutr. 2025 Aug;51:349-361. doi: 10.1016/j.clnu.2025.07.004. Epub 2025 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether daily supplementation with the probiotic Bifidobacterium breve BBr60 can improve metabolic, gastrointestinal, and emotional health in healthy adult volunteers aged 19 to 45 years.\n\nThe main questions it aims to answer are: Can B. breve BBr60 improve lipid metabolism (e.g., increase HDL and reduce total cholesterol) in healthy adults? Can B. breve BBr60 alleviate gastrointestinal symptoms and improve emotional well-being in a non-clinical population? Researchers will compare a BBr60 supplementation group to a placebo group to see if the probiotic group experiences greater improvements in metabolic, gastrointestinal, and psychological indicators.\n\nParticipants will: Take one sachet daily of either B. breve BBr60 (10 billion CFU) or placebo for 8 weeks. Provide blood and stool samples at baseline and week 8. Complete validated questionnaires assessing alcohol dependence, gastrointestinal symptoms, and emotional status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 19-45 years;\n2. Willing to voluntarily agree to and comply with the trial protocol, and capable of timely participation in screening and follow-up;\n3. Have not suffered from gastrointestinal diseases in the past month;\n4. Have not taken antibiotics in the past month.\n\nExclusion Criteria:\n\n1. Individuals under 19 or over 45 years of age, with an allergic constitution or allergy to any component of the test substance, symptoms of alcohol allergy, and pregnant or breastfeeding women;\n2. Those who experience discomfort such as diarrhea or bloating after taking the test substance;\n3. Patients with serious diseases of the cardiovascular, liver, kidney, hematopoietic systems, autoimmune diseases, endocrine disorders, mental illnesses, existing high blood sugar, or unhealthy gastrointestinal conditions;\n4. Those who discontinue the test sample or take other medications midway, making it difficult to judge efficacy or with incomplete data;\n5. Recently taken probiotics, prebiotics, or antibiotics related to the function of the test substance, affecting the judgment of results;\n6. Individuals with a daily diet that is either too light or too greasy; those with special dietary structures due to weight loss or other reasons (such as a ketogenic diet);\n7. Individuals with low body fat, BMI \\< 23.'}, 'identificationModule': {'nctId': 'NCT06196892', 'briefTitle': "Probiotics Improve Health Young Volunteers' Gut Microbiota", 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind Controlled Trial to Assess the Impact of Probiotic on the Intestinal Health of Individuals', 'orgStudyIdInfo': {'id': 'WK2023007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'one sachet per day, with maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': 'one sachet per day, with BBr60 and maltodextrin', 'interventionNames': ['Dietary Supplement: Probiotic BBr60']}], 'interventions': [{'name': 'Probiotic BBr60', 'type': 'DIETARY_SUPPLEMENT', 'description': "Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking BBr60.", 'armGroupLabels': ['Probiotic group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': "Collect patient fecal samples, test for 16S rRNA, and analyze the changes in the patient's gut microbiota before and after taking maltodextrin.", 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210095', 'city': 'Nanjing', 'state': 'None Selected', 'country': 'China', 'facility': 'Kang Zou', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}