Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03876327
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2019-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation As a Potential Treatment for 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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 groups were included in the study:\n\n1. PD patients that will undergo FMT tretment and a half of year follow-up-15 patients.\n2. PD patients that will not undergo FMT procedure and will donate stool sample only once-35 patients.\n3. healthy PD relatives, that live with them and have similiar life styling and which will donate stool sample only once-50 participants.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-02', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'motor parkinsonian symptoms', 'timeFrame': 'Change from baseline motor difficulties at 6 months', 'description': 'motor symptoms assessed by UPDRS III questionaire'}, {'measure': 'constipation level', 'timeFrame': 'Change from baseline constipation level at 6 months', 'description': 'constipation will be assessed by a scoring system questionaire. 6 parameters are reviewed as scored fro 0 (mild symptom) to 4 (srvere symptom).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '34237681', 'type': 'DERIVED', 'citation': "Segal A, Zlotnik Y, Moyal-Atias K, Abuhasira R, Ifergane G. Fecal microbiota transplant as a potential treatment for Parkinson's disease - A case series. Clin Neurol Neurosurg. 2021 Aug;207:106791. doi: 10.1016/j.clineuro.2021.106791. Epub 2021 Jun 30."}]}, 'descriptionModule': {'briefSummary': "this pilot study aims to further explore the potential usage of Fecal microbiota transplantation in treating constipation and possibly also motor symptoms in Parkinson's disease (PD) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and PD.", 'detailedDescription': "Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.\n\nParkinson's disease (PD) is a neurodegenerative disorder characterized by motor symptoms and Gastrointestinal dysfunction, in particular constipation, affects up to 80% of PD patients and may precede the onset of motor symptoms by years.\n\nthis study include one group of PD patients that will receive FMT. two other groups will serve as controls:\n\n1. PD patients that will not receive FMT\n2. healthy people who live with PD patients in the same house and share similar surrounding"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged \\> 50 years, diagnosed as suffering from PD and under follow up of the Movement Disorders Clinic in Soroka University Medical Center.\n* Subjects complaining of constipation .\n* Subjects who did not perform a screening colonoscopy for colon cancer.\n* Subjects who are clinically undertreated according to last Movement Disorders specialist's impression at the clinic visit.\n\nExclusion Criteria:\n\n* Subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically.\n* Subjects who already underwent a screening colonoscopy for colon cancer.\n* Subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy."}, 'identificationModule': {'nctId': 'NCT03876327', 'briefTitle': "Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': "Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease: A Pilot Study", 'orgStudyIdInfo': {'id': '0266-15-SOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD patients that will receive FMT', 'description': 'fecal microbial transplantation once at the beginning of the study-15 patients.', 'interventionNames': ['Procedure: fecal microbial transplantation']}, {'type': 'NO_INTERVENTION', 'label': 'PD patients that will not receive FMT', 'description': 'do not receive treatment-35 patients.'}, {'type': 'NO_INTERVENTION', 'label': 'healthy people live with PD patients', 'description': 'do not receive treatment-50 participants.'}], 'interventions': [{'name': 'fecal microbial transplantation', 'type': 'PROCEDURE', 'description': "Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.", 'armGroupLabels': ['PD patients that will receive FMT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '151', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'arik segal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SOROKA MC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ARIK SEGAL MD', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}