Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-24 @ 3:18 PM
Study NCT ID:
NCT06848192
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-02-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Parkinson's Disease Case-Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'description': 'Blood (10 mL), stool sample (10 g), random midstream urine (12 mL)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiome profiling', 'timeFrame': 'At enrollment', 'description': 'The microbiome profile is analyzed based on stool samples.'}], 'secondaryOutcomes': [{'measure': 'Fecal and serum metabolomics profiling', 'timeFrame': 'At enrollment', 'description': 'Metabolomics profiles are analyzed based on blood samples and stool samples.'}, {'measure': 'Blood and urine proteomics profiling', 'timeFrame': 'At enrollment', 'description': 'Proteomics profiles are analyzed based on blood samples and urine samples.'}, {'measure': 'Brain imaging features', 'timeFrame': 'At enrollment', 'description': 'MRI scans are used to extract brain imaging features.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The Parkinson's Disease Case-Control Study is a study of healthy volunteers and patients with Parkinson's disease aged 50-75 years living in Hangzhou, China. This study aims to systematically investigate the differences in intestinal fungi between patients and healthy volunteers, find the key strains, and explore the molecular mechanism of Parkinson's disease with multi-omics data. Another aim of this study is to explore the association between intestinal fungi and brain structure and function from the perspective of the gut-brain axis by combining brain image data.", 'detailedDescription': "Parkinson's disease is the second most common neurodegenerative disease of the central nervous system. Recent studies have shown that gut microorganisms, through their metabolites, can directly and indirectly affect brain function and neurodegenerative processes through the immune system, endocrine system, and nervous system, thus affecting the progress of Parkinson's disease. Gut fungi, as an important component of gut microorganisms, are rarely studied in Parkinson's disease. To systematically explore the differences in intestinal fungi between patients with Parkinson's disease and healthy volunteers, this project is expected to recruit 20 healthy volunteers and 20 Parkinson's disease patients respectively. The Parkinson's Disease Case-Control Study design incorporates collecting demographic information and clinical characteristics of Parkinson's disease patients and healthy volunteers, as well as biological samples (blood, urine, stool) and brain magnetic resonance imaging (MRI) of the subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the participants should be residents living in Hangzhou, China', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n(For PD patients)\n\n1. Men or women aged 50 to 75 years.\n2. Clinical diagnosis of Parkinson's disease (based on MDS Parkinson's disease diagnostic criteria)\n3. The patient must have at least two of the following symptoms: static tremor, bradykinesia, stiffness (which must include at least static tremor or bradykinesia); Or have asymmetrical resting tremors or asymmetrical bradykinesia.\n4. Able to provide informed consent.\n\n(For healthy volunteers)\n\n1. Age (±2 years) and sex-matched healthy control individuals for each Parkinson's disease patient.\n2. Able to provide informed consent.\n\nExclusion Criteria:\n\n(For PD patients)\n\n1. Atypical or secondary parkinsonism due to medications (e.g., metoclopramide, flunarizine, antipsychotics) or metabolic diseases (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).\n2. The presence of clinically diagnosed dementia as determined by the investigator.\n3. Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).\n4. Serious illness (e.g., heart failure or malignancy).\n5. Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction\n6. Inflammatory gastrointestinal diseases.\n7. Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).\n8. Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.\n9. Antibiotics have been used within 3 months prior to sample collection.\n10. Chronic constipation.\n\n(For healthy volunteers)\n\n1. Have a first-degree relative with Parkinson's disease (e.g. biological parent, sibling, or child).\n2. Current or past clinically significant neurological disorders (as judged by the investigator).\n3. Previous MRI scans showed clinically significant neurological disorders (as judged by the investigator).\n4. Use of the following drugs in the 6 months prior to the screening visit: dopamine blockers (antipsychotics), metoclopramide, and riserpine.\n5. Inflammatory gastrointestinal diseases.\n6. Smoking more than 15 cigarettes a day and a history of alcohol or drug addiction\n7. Chronic diseases that may affect the gut microorganism (e.g., diabetes, cirrhosis, or cardiovascular disease).\n8. Blood or autoimmune disease, or use of immunosuppressants in the past 3 months.\n9. Antibiotics have been used within 3 months prior to sample collection.\n10. Chronic constipation.\n11. Participating in other clinical trials"}, 'identificationModule': {'nctId': 'NCT06848192', 'briefTitle': "The Parkinson's Disease Case-Control Study", 'organization': {'class': 'OTHER', 'fullName': 'Westlake University'}, 'officialTitle': "The Parkinson's Disease Case-Control Study: Gut Microbiome Study for Parkinson's Disease", 'orgStudyIdInfo': {'id': '20250115ZJS001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ju-Sheng Zheng, PhD', 'role': 'CONTACT', 'email': 'zhengjusheng@westlake.edu.cn', 'phone': '86-0571-86915303'}, {'name': 'Ju-sheng Zheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ju-Sheng Zheng, PhD', 'role': 'CONTACT', 'email': 'zhengjusheng@westlake.edu.cn', 'phone': '86-0571-86915303'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Westlake University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}