Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-03 @ 12:44 AM
Study NCT ID:
NCT03827733
Status:
UNKNOWN
Last Update Posted:
2021-04-19
First Post:
2018-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiota and Alzheimer's Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Fecal sample collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut beta-amyloid 42', 'timeFrame': 'Through study completion, an average of 4 year', 'description': 'Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot.'}], 'secondaryOutcomes': [{'measure': 'Gut microbiota', 'timeFrame': 'Through study completion, an average of 4 year', 'description': 'We will use DNA sequencing to define the profile of gut microbiota.'}, {'measure': 'Oral microbiota', 'timeFrame': 'Through study completion, an average of 4 year', 'description': 'We will use DNA sequencing to define the profile of gut microbiota.'}, {'measure': 'Cognitive function by Mini-mental State Examination (MMSE)', 'timeFrame': 'through study completion, an average of 4 year', 'description': 'We will assess the cognitive function in the participants using MMSE to promote the diagnosis of AD in these participants. The sum of MMSE ranges from 0 (worse) to 30 (better).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut Microbiota', "Alzheimer's Diseases"], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The investigator will perform clinical studies to test a hypothesis that participants who have Alzheimer's disease will have different gut/oral microbiota profile as compared to the participants who do not have Alzheimer's disease. The investigators will also check the microbiome of their partners in this study. The investigators plan to perform the studies in 150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai city. Investigators will also measure the beta-amyloid in the feces of the participants. Finally, the investigators will determine cognitive function in these participants.", 'detailedDescription': "Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant impact on the behavior and brain pathology consistent with Alzheimer's disease (AD) neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome and feces beta-amyloid of AD patients are different from those of the participants without AD and their partners. The investigators plan to recruit 150 subjects, including three groups of normal elders, AD patients and the partners of the AD patients. The cognitive function will be assessed and the feces and oral samples will be collected to determine whether there are differences or correlations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Elderly participants with normal congition will be collected from community. Alzheimer's disease participants and their spouse will be collected from Shanghai Tenth People's Hopital.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 60 and older\n\nExclusion Criteria:\n\n* with other acute gastrointestinal diseases\n* with other severe neuropsychiatric disorders'}, 'identificationModule': {'nctId': 'NCT03827733', 'briefTitle': "Gut Microbiota and Alzheimer's Diseases", 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': "Gut Microbiota and Alzheimer's Diseases", 'orgStudyIdInfo': {'id': 'dsyy004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AD patients', 'description': 'Participants who are diagnosed with AD.'}, {'label': 'Partners of the AD patients', 'description': 'Partners of AD patients who live together with the AD patients.'}, {'label': 'Elderly participants with normal cognition', 'description': 'Community dwelling elderly with normal cognition and with AD.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanxia Guo, M.D.', 'role': 'CONTACT', 'email': 'guoyx_2000@tongji.edu.cn', 'phone': '021-65982875'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yuan Shen, MD, PhD', 'role': 'CONTACT', 'email': 'kmshy@tongji.edu.cn', 'phone': '02166303649'}, {'name': 'Zhongyong Shi, MD', 'role': 'CONTACT', 'email': 'szy0721@126.com', 'phone': '18701915271'}], 'overallOfficials': [{'name': 'Yuan Shen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Psychiatry Department', 'investigatorFullName': 'Yuan Shen, MD, PhD', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}