Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-28 @ 8:44 PM
Study NCT ID:
NCT04976959
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Fiber 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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in microbiome composition', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of the research is to determine the effects of a high-fiber nutritional supplement (HFS) on the bacteria, viruses, and fungi that live in different regions of the body in those with Parkinson's disease (PD). We will compare the bacteria, viruses, and fungi of those with PD to those without PD (healthy controls). We will also examine the effects of transplanting stool from humans into laboratory mice with or without Parkinson-like pathology to understand how the microbiome influences the brains of animals. We can use this information to get a better understanding of how changing the microbiome might help humans."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease patients who are untreated\n\nExclusion Criteria:\n\n* Occupation expected to change the microbiome (e.g. sanitation worker)\n* Treatment with medications that may induce parkinsonism (e.g. metoclopramide, typical or atypical antipsychotic agents)\n* Treatment within 12 weeks with oral or intravenous antibiotics\n* Known diagnosis of inflammatory bowel disease\n* Symptomatic organic gastrointestinal (GI) disease (other than hemorrhoids and hiatal hernia) or abdominal surgeries for symptomatic gastrointestinal disease such as bowel resection, diverticular surgery, colostomy; subjects with a history of an appendectomy or gallbladder removal for non-cancerous disease more than 5 years prior to presentation are allowed.\n* Symptomatic functional GI disease that significantly impairs intestinal motility such as scleroderma or use of GI motility drugs\n* Acute illness requiring immediate hospitalization\n* Pre-existent conditions as below:\n* Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X\\> normal);\n* Kidney disease (creatinine\\>2.0 mg/dL);\n* Uncontrolled psychiatric illness;\n* Clinically important lung disease or heart failure;\n* HIV disease;\n* Alcoholism, unreliable drinking history; or consumption of alcohol more than 3 times a week or binge drinking or drinking more than or equal to 3 drinks per occasion;\n* Transplant recipients;\n* Diabetes;\n* BMI \\> 30\n* Clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure\n* Presence of short bowel syndrome or severe malnutrition with ideal body weight \\< or = 90%\n* Use of immunosuppressive medications in 3 months prior to enrollment\n* Anti-inflammatory medication use within 3 weeks of enrollment.\n* Chronic use of diuretics"}, 'identificationModule': {'nctId': 'NCT04976959', 'briefTitle': "High Fiber in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': "High Fiber in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'Pro2021000121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Parkinson's patients", 'description': "Parkinson's patients who will receive a high fiber supplement", 'interventionNames': ['Drug: High Fiber supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Control subjects', 'description': 'no supplement will be given'}], 'interventions': [{'name': 'High Fiber supplement', 'type': 'DRUG', 'description': 'The supplement consists of a mixture of soluble fibers (from inulin and fibersol-2) and insoluble fibers (from oat bran, corn bran, wheat bran and sorghum bran) and it will be consumed as a drink.', 'armGroupLabels': ["Parkinson's patients"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers-RWJ University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Gian Pal, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gian Dev Pal, MD, MS', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}