Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 8:21 AM
Study NCT ID:
NCT07287306
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of BLa80 and LRa05 on the Gut Microbiota Metabolite Profile of Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum metabolomic profiles measured by HPLC-MS/MS', 'timeFrame': 'Baseline (week 0), week 4, and week 8 post intervention', 'description': 'Untargeted serum metabolomic profiling will be performed using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) to assess changes in circulating metabolite concentrations over time.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Individuals']}, 'descriptionModule': {'briefSummary': 'Gut microbiota play a key role in polyphenol metabolism, participating in the breakdown of dietary components and producing various small molecule metabolites that affect human health. However, little is currently known about how gut microbes metabolize dietary compounds and produce bioactive metabolites. This study aims to use metabolomics to precisely identify food-derived metabolites in the blood to investigate whether probiotics (BLa80, LRa05) can enhance the breakdown of dietary components and improve their absorption and utilization in the human body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female participants aged 18 to 60 years;\n2. Healthy individuals;\n3. Participants must provide written informed consent.\n\nExclusion Criteria:\n\n1. History of gastrointestinal surgery, other gastrointestinal diseases, metabolic disorders, immunodeficiency, hyperthyroidism, or cardiac or liver disease;\n2. Use of immunosuppressants;\n3. Pregnant or breastfeeding women;\n4. Participants who have taken antibiotics or probiotics within the previous 3 months;\n5. Planned surgery during the study period;\n6. Patients with neurological disorders or psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT07287306', 'briefTitle': 'Effects of BLa80 and LRa05 on the Gut Microbiota Metabolite Profile of Healthy Individuals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'Effects of BLa80 and LRa05 on the Gut Microbiota Metabolite Profile of Healthy Individuals: A Randomized, Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'WK20251120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Each placebo stick contained 3 g of dextrin. Dosage: one stick per day.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BLa80', 'description': 'Each probiotic stick contained dextrin and 2 × 10¹⁰ CFU BLa80. Dosage: one stick per day.', 'interventionNames': ['Dietary Supplement: BLa80']}, {'type': 'EXPERIMENTAL', 'label': 'LRa05', 'description': 'Each probiotic stick contained dextrin and 2 × 10¹⁰ CFU LRa05. Dosage: one stick per day.', 'interventionNames': ['Dietary Supplement: LRa05']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).', 'armGroupLabels': ['Placebo']}, {'name': 'BLa80', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).', 'armGroupLabels': ['BLa80']}, {'name': 'LRa05', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study will last 8 weeks and each subject will receive 3 follow-up visits (week 0, week 4, week 8).', 'armGroupLabels': ['LRa05']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yijun Zhu, Doctor', 'role': 'CONTACT', 'email': 'zhuyj67@mail.sysu.edu.cn', 'phone': '13922101450', 'phoneExt': '+86'}], 'facility': 'The First Affiliated Hospttal, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}