Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT05576818
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Synbiotic as an Adjuvant Therapy in the Treatment of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The change in MDS-Unified Parkinson's Disease Rating Scale.", 'timeFrame': '3 months', 'description': "Patients will undergo clinical assessment according to MDS-Unified Parkinson's Disease Rating Scale at baseline and after 3 months"}], 'secondaryOutcomes': [{'measure': 'The change in the serum level of α-Synuclein', 'timeFrame': '3 months', 'description': 'Blood samples will be collected at baseline and after 3 months'}, {'measure': 'The change in the serum level of Tumor necrosis factor α (TNF α )', 'timeFrame': '3 months', 'description': 'Blood samples will be collected at baseline and after 3 months'}, {'measure': 'The change in the serum level of Brain derived neurotrophic factor ( BDNF)', 'timeFrame': '3 months', 'description': 'Blood samples will be collected at baseline and after 3 months'}, {'measure': 'The change in the serum level of Malondialdehyde (MDA)', 'timeFrame': '3 months', 'description': 'Blood samples will be collected at baseline and after 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '40434674', 'type': 'DERIVED', 'citation': "Ramadan ME, Mostafa TM, Ghali AA, El-Afify DR. Randomized controlled trial evaluating synbiotic supplementation as an adjuvant therapy in the treatment of Parkinson's disease. Inflammopharmacology. 2025 Jul;33(7):3897-3908. doi: 10.1007/s10787-025-01752-8. Epub 2025 May 28."}]}, 'descriptionModule': {'briefSummary': "This study aims to investigate the possible efficacy and safety of synbiotic preparation of Lactobacillus acidophilus probiotic with prebiotic fibers as an adjuvant therapy in the treatment of Parkinson's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 45 and 65 years old\n* Both sexes\n* Patients with Parkinson's disease on dopamine replacement therapy\n* Modified Hoehn and Yahr stage, MHY 1-4\n\nExclusion Criteria:\n\n* Patients who are currently using or used antibiotics therapy in the preceding month\n* Patients who are currently using or used other probiotic products in the preceding two weeks\n* Patients scheduled to undergo GIT surgery or those underwent GIT surgery\n* Patients with Known allergy to probiotics\n* Patients receiving artificial enteral or intravenous nutrition\n* Patients with depression and/or psychosis\n* Patients taking antioxidant and/or anti-inflammatory medications\n* Patients with Hyperthyroidism\n* Patients with inflammatory condition and/or condition involving oxidative stress\n* Smokers\n* Modified Hoehn \\& Yahr stage MHY 5"}, 'identificationModule': {'nctId': 'NCT05576818', 'briefTitle': "Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': "Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease", 'orgStudyIdInfo': {'id': "Synbiotics Parkinson's disease"}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'this group will include 33 patients who will receive their standard dopamine replacement therapy for 3 months'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Synbiotic group', 'description': 'this group will involve 33 patients who will receive Synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers 2 sachets daily together with their standard dopamine replacement therapy for 3 months', 'interventionNames': ['Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers']}], 'interventions': [{'name': 'Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers', 'type': 'DRUG', 'otherNames': ['Synbiotic'], 'description': 'Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers', 'armGroupLabels': ['Synbiotic group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'El Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed E Ramadan', 'role': 'CONTACT', 'email': 'mohamed_ehab@pharm.tanta.edu.eg', 'phone': '201205280849'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mohamed E Ramadan', 'role': 'CONTACT', 'email': 'mohamed_ehab@pharm.tanta.edu.eg', 'phone': '201205280849'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Demonstrator at clinical pharmacy department, faculty of pharmacy', 'investigatorFullName': 'Mohamed Ehab Sayed Ramadan', 'investigatorAffiliation': 'Tanta University'}}}}