Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT06594406
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oral Bifidobacterium on Exogenous Creatine Absorption in Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Hamilton Depression Rating Scale', 'timeFrame': '4 weeks', 'description': 'Comparison of Hamilton Depression Rating Scale before and after treatment'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in creatine level in blood', 'timeFrame': '4 weeks', 'description': 'Comparison of creatine level in blood before and after treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to learn if Bifidobacterium has antidepressant-like effects by enhancing creatine absorption in adults. The main questions to be answered are\n\nDoes Bifidobacterium combined with creatine have better antidepressant effects? Does Bifidobacterium enhance exogenous creatine uptake?\n\nResearchers will compare bifidobacterium combined with creatine with placebo to see if bifidobacterium combined with creatine has antidepressant effects.\n\nParticipants will:\n\nTake bifidobacterium, creatine or placebo every day for 4 weeks. Keep a diary of their symptoms and collect blood samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for depression:\n\n* Adults age 18-60 years inclusive.\n* Current diagnosis of major depression disorder (MDD) identified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5).\n* Current Hamilton Depression Scale 17 score of \\> 16.\n* BMI (body Mass Index) between 18 and 28 kg/m²\n* Right-handed\n\nExclusion Criteria:\n\n* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5.\n* History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)\n* History of seizure disorder\n* Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale\n* Previous diagnosis of creatine deficiency syndrome or evidence of creatine deficiency syndrome\n* Antibiotic use in last 30 days\n* Probiotics use in last 30 days\n* Positive pregnancy test\n* Breastfeeding'}, 'identificationModule': {'nctId': 'NCT06594406', 'briefTitle': 'The Effect of Oral Bifidobacterium on Exogenous Creatine Absorption in Adult Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Zhujiang Hospital'}, 'officialTitle': 'The Therapeutic Effects of Combining Bifidobacterium With Creatine on Depression', 'orgStudyIdInfo': {'id': 'zhujiangjy-0108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy individuals with creatine', 'interventionNames': ['Dietary Supplement: Creatine']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy individuals with creatine and bifidobacterium', 'interventionNames': ['Dietary Supplement: Bifidobacterium and creatine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Depression individuals with placebo', 'description': 'Depressed individuals with placebo and antidepressants', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Depression individuals with creatine and bifidobacterium', 'description': 'Depression individuals with creatine and bifidobacterium and antidepressants', 'interventionNames': ['Dietary Supplement: Bifidobacterium and creatine']}], 'interventions': [{'name': 'Creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The dosing schedule of creatine administration is 3 g daily for 4 weeks, and administration of a placebo.', 'armGroupLabels': ['Healthy individuals with creatine']}, {'name': 'Bifidobacterium and creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The dosing schedule of creatine administration is 3 g daily for 4 weeks. In parallel, the dosing schedule of bifidobacterium administration is 200 million colony-forming units (CFU) /day for 4 weeks.', 'armGroupLabels': ['Depression individuals with creatine and bifidobacterium', 'Healthy individuals with creatine and bifidobacterium']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of creatine placebo and bifidobacterium placebo for 4 weeks,', 'armGroupLabels': ['Depression individuals with placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Southern medical university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xiong Cao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yan He', 'investigatorAffiliation': 'Zhujiang Hospital'}}}}