Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-16 @ 1:31 AM
Study NCT ID:
NCT03705520
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting Diet-Microbiome Interactions in the Pathogenesis 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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-28', 'size': 1286008, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-05T17:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-08', 'studyFirstSubmitDate': '2018-10-01', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study microbiome composition to explain the exact nature of the dysbiosis (microbial imbalance)', 'timeFrame': '4 years', 'description': 'The investigators anticipate confirming their prior findings that patients with PD have dysbiosis, and further identifying the nature of the dysbiosis including changes at the species and strain level.'}], 'secondaryOutcomes': [{'measure': 'Identify the potential contributing factors for dysbiosis in PD', 'timeFrame': '4 years', 'description': 'It is well established that environmental factors such as diet, as well as genetics, impact microbiome composition.Currently, there are no data for how environment impacts the microbiome in PD.'}, {'measure': 'Determine how dysbiosis promotes PD', 'timeFrame': '4 years', 'description': 'The investigators will determine SCFA (Short chain fatty acids) concentrations in serum and stool from early onset PD patients and healthy controls. The investigators will correlate serum, stool data, PD symptoms and disease severity obtained through validated PD questionnaires.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD', "Parkinson's", "Parkinson's Disease", 'Microbiome'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the microbiome of medicated and non-medicated subjects diagnosed with Parkinson's disease. Where available, in comparison to the microbiome of a healthy spouse or 1st degree relative.", 'detailedDescription': 'First, a cross sectional study where the investigators will compare microbiome composition in subsets of PD and Multiple System Atrophy (MSA) patients whose household control agree to provide stool samples as well. Each household control subject will be evaluated to ensure there is no clinical evidence of neurological disorders including PD. Also, these subjects will complete a 24 hour diet recall questionnaire before stool collection and validated 3 month food frequency questionnaire to collect dietary information similar to PD patients. Each subject (including PD subjects) will complete a smell questionnaire and a sleep questionnaire to determine whether these "control" subjects have loss of smell or have REM sleep disorders because these conditions increase the risk of PD. For assessing smell, investigators will use the UPSIT questionnaire. For assessing REM sleep disorder, investigators will use RBD1Q which consists of a single question, answered "yes" or "no," as follows: "Has the subject ever been told, or suspected themselves that they seem to \'act out their dreams\' while asleep (for example, punching, flailing their arms in the air, making running movements, etc.)?"\n\nSecond, in the longitudinal study, the investigators will collect stool every 3 months with 3 day diet questionnaire prior to each collection over 12 months and determine microbiome composition over time. Investigators will correlate the microbiome data with PD symptoms, diet and response to treatment and progression of disease. These studies will determine whether disease progression and factors such as PD medications and diet significantly impact microbiome composition. Furthermore, the investigators will determine whether changes in SCFA-producing bacteria and/or abnormal SCFA profiles correlate with severity of PD symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population will be selected from the neurology clinic, as well as a self-referrals.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPD Subjects Inclusion:\n\n* 40-80 years of age\n* Previously diagnosed with Parkinson's disease\n* Parkinson's disease stage between 1-4\n* Are willing to participate in the study\n\nHealthy control/ Spouse/ 1st degree relative Inclusion:\n\n* Adults 40-80 years of age\n* No clinical evidence of neurological disorders including Parkinson's disease\n* Live in the same household as the Parkinson Disease patient or is a first degree relative of the PD patient or an independent healthy control\n* Are willing to participate in the study\n\nExclusion Criteria:\n\nPD Subjects Exclusion:\n\n* History of GI diseases (except for hemorrhoids or occasional (\\<3 times a week) heartburn) like Inflammatory bowel disease or Celiac disease.\n* Antibiotic use within last 12 weeks.\n* Use of probiotic supplement except yogurt.\n* Intentional change in diet.\n* Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed.\n\nHealthy control/ Spouse/ 1st degree relative Exclusion:\n\n* History of GI diseases (except for hemorrhoids or occasional (\\<3 times a week) heartburn) like Inflammatory bowel disease or Celiac disease.\n* Antibiotic use within last 12 weeks.\n* Use of probiotic supplement except yogurt.\n* Intentional change in diet.\n* Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed"}, 'identificationModule': {'nctId': 'NCT03705520', 'briefTitle': "Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': "Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease", 'orgStudyIdInfo': {'id': 'ORA 16111903'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cross-Sectional', 'description': 'This cohort is composed of only medicated PD subjects and their spouse or 1st degree relative.'}, {'label': 'Logitundinal', 'description': 'This cohort is composed of only non-medicated PD subjects and their spouse or first degree relative.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Ali Keshavarzian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}, {'name': 'Gian Pal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush Univeristy Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No identifying information will be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Institute of Technology', 'class': 'OTHER'}, {'name': 'Purdue University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Digestive Diseases', 'investigatorFullName': 'Ali Keshavarzian', 'investigatorAffiliation': 'Rush University Medical Center'}}}}