Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 10:12 PM
Study NCT ID:
NCT06548256
Status:
RECRUITING
Last Update Posted:
2024-08-12
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Drug: Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year Drug: observed for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3", 'timeFrame': '0, 3, 12, 15, 24 months', 'description': "Part 3 of this scale assesses motor performance in 33 items. Each item is scored on a scale of 0 (normal) to 4 (severe), with a total score range of 0 to 132, and higher scores mean the patient's situation is worse."}, {'measure': 'Hamilton Depression Rating Scale (HAM-D)', 'timeFrame': '0, 3, 12, 15, 24 months', 'description': 'This scale assesses non-motor symptoms in 17 items, the total scale value is 50 (Scores 0 to 7 mean normal, 8 to 13 mean mild depression, 14 to 18 mean moderate depression, 19 to 22 mean severe depression, and ≥23 mean very severe depression).'}, {'measure': 'Hamilton Anxiety Scale (HAM-A)', 'timeFrame': '0, 3, 12, 15, 24 months', 'description': 'This scale assesses non-motor symptoms in 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where ≤17 indicates mild anxiety severity, 18-24 indicate mild to moderate anxiety severity, 25-30 indicate moderate to severe anxiety severity, \\>30 indicate severe anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clostridium Butyricum Miyairi', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This is an open-label, single-center, non-randomized study to assess the efficacy of Clostridium Butyricum Miyairi on the motor and non-motor symptoms of Parkinson's disease", 'detailedDescription': 'The physician will explain the trial procedures in the outpatient, and then obtain the written informed consent to start the interview. And randomly divided into experimental and observation groups, and according to the timing of taking Miyarisan, scale evaluation and sample collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female over 20 years old, diagnosed with Parkinson's disease.\n\nExclusion Criteria:\n\n* People with Parkinson's disease Dementia, or Lactose Intolerance"}, 'identificationModule': {'nctId': 'NCT06548256', 'briefTitle': "The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': "The Clinical Application of Clostridium Butyricum Miyairisan for Motor and Non-motor Symptoms in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'KMUHIRB-F(I)-20220001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miyarisan-BM (Clostridium Butyricum Miyairi) first', 'description': 'Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year, then stopped for 1 year', 'interventionNames': ['Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)']}, {'type': 'EXPERIMENTAL', 'label': 'Miyarisan-BM (Clostridium Butyricum Miyairi) later', 'description': 'observation for 1 year and then Miyarisan-BM (Clostridium Butyricum Miyairi) for 1 year.', 'interventionNames': ['Drug: Miyarisan-BM (Clostridium Butyricum Miyairi)']}], 'interventions': [{'name': 'Miyarisan-BM (Clostridium Butyricum Miyairi)', 'type': 'DRUG', 'description': 'probiotics', 'armGroupLabels': ['Miyarisan-BM (Clostridium Butyricum Miyairi) first', 'Miyarisan-BM (Clostridium Butyricum Miyairi) later']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yang-Pei Chang, M.D.; MSc,', 'role': 'CONTACT', 'email': 'cyp905@gmail.com', 'phone': '886-7-2911101', 'phoneExt': '8913'}], 'facility': 'Kaohsiung Medical Univeristy Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Yang-Pei Chang, M.D.; MSc.', 'role': 'CONTACT', 'email': 'cyp905@gmail.com', 'phone': '886-7-2911101', 'phoneExt': '8913'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}