Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-04 @ 12:45 AM
Study NCT ID:
NCT05446168
Status:
TERMINATED
Last Update Posted:
2025-01-23
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C005830', 'term': 'tributyrin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nbohnen@umich.edu', 'phone': '734-936-1168', 'title': 'Nicolaas Bohnen, MD, PhD', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For all subjects, data was collected during the 30 +/- 7 days of tributyrin intervention.', 'eventGroups': [{'id': 'EG000', 'title': "Parkinson's Disease Tributyrin Intervention", 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Control Tributyrin Intervention', 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'GI Discomfort', 'notes': 'Related, mild, expected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Behavioral Disturbance', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep Disruption', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shakiness/Dyskinesia', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe Injury', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Claustrophobia', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Infection', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gait Disturbances', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg Swelling', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Blood Glucose', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'notes': 'Unrelated, mild, unexpected AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Whole Brain Butyrate PET Radiotracer Binding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Parkinson's Disease Tributyrin Intervention", 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}, {'id': 'OG001', 'title': 'Healthy Control Tributyrin Intervention', 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}], 'classes': [{'title': 'Pre-intervention', 'categories': [{'measurements': [{'value': '1.81', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '0.02', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '-0.03', 'pValueComment': 'A priori threshold for statistical significance is p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 't = -4.05, df = 7', 'nonInferiorityComment': 'A comparison is not being made between two different treatment groups. Exploratory analysis'}], 'paramType': 'MEAN', 'timeFrame': 'Pre and Post approximately 30 days of intervention', 'description': 'Whole-brain butyrate distribution volume ratios (DVRs) were computed relative to a cerebral white matter reference region pre and post approximately 30 days of open-label treatment with tributyrin. Lower radiotracer binding is interpreted to reflect higher levels of (non-tracer) butyrate in the brain, whereas higher radiotracer binding reflects higher butyrate receptor binding site availability, indicating lower levels of non-tracer butyrate in the brain.', 'unitOfMeasure': 'Parametric DVR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Brain imaging was not strictly required for participation in the remaining components of the study. Not all participants underwent PET imaging. Healthy control sample size (n=2) was not sufficient to perform statistical analysis for that group.'}, {'type': 'PRIMARY', 'title': 'Glucose Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Parkinson's Disease Tributyrin Intervention", 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}, {'id': 'OG001', 'title': 'Healthy Control Tributyrin Intervention', 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}], 'classes': [{'title': 'Pre-Intervention', 'categories': [{'measurements': [{'value': '135.00', 'spread': '49.39', 'groupId': 'OG000'}, {'value': '104.50', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Post-Intervention', 'categories': [{'measurements': [{'value': '139.33', 'spread': '53.31', 'groupId': 'OG000'}, {'value': '125.00', 'spread': '4.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.33', 'ciLowerLimit': '-3.81', 'ciUpperLimit': '12.47', 'pValueComment': 'A priori threshold for statistical significance is p \\< 0.05.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.81', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 't = 1.17, df = 11', 'nonInferiorityComment': 'A comparison is not being made between two different treatment groups. Exploratory analysis.'}], 'paramType': 'MEAN', 'timeFrame': 'Pre and Post approximately 30 days of intervention', 'description': 'Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the SCFA prodrug tributyrin in patients with PD and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL withing 2 hours of eating meals.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "2 Parkinson's disease participants did not complete continuous glucose monitoring due to scheduling conflicts, thus only 14/16 participants were included in this analysis. Healthy control sample size (n=2) was not sufficient to perform statistical analysis for that group."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Parkinson's Disease Tributyrin Intervention", 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}, {'id': 'FG001', 'title': 'Healthy Control Tributyrin Intervention', 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': "18 participants were enrolled in the study. One Parkinson's disease subject withdrew prior to beginning study procedures and thus is not counted as started."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Parkinson's Disease Tributyrin Intervention", 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}, {'id': 'BG001', 'title': 'Healthy Control Tributyrin Intervention', 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.\n\ntributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '66.5', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '19.3', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '18.1', 'spread': '2.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III", 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '20.5', 'groupId': 'BG001'}, {'value': '43.6', 'spread': '15.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 is a clinician-administered motor exam consisting of 18 items to evaluate the motor symptom severity in Parkinson's disease. Total scores range from 0 to 132, with higher scores indicating higher severity of motor symptoms. MDS-UPDRS Part 3 scores of 32 and below are typically considered mild, 33-58 is moderate, and 59 and above considered severe.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Montreal Cognitive Assessment (MoCA)', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Montreal Cognitive Assessment (MoCA) is used for detection of mild cognitive impairment. It assesses short-term memory, visuospatial abilities, executive functioning, attention, language, and orientation. Scores range from 0 to 30, with low scores indicating more cognitive impairment. Scores of 26 and above indicate normal cognitive performance, 18-25 indicate mild impairment, 10-17 indicate moderate impairment, and 0-9 indicate severe impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Parkinson's Disease Cognitive Rating Scale (PDCRS)", 'classes': [{'categories': [{'measurements': [{'value': '92.0', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '96.3', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '92.8', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Parkinson's Disease Cognitive Rating Scale (PDCRS) evaluates cognition in Parkinson's disease. Scores range from 0-134 with lower scores indicating increased cognitive impairment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-23', 'size': 565058, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-23T13:25', 'hasProtocol': True}, {'date': '2023-03-09', 'size': 704251, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-01T14:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Withdrawal of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2022-07-01', 'resultsFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-20', 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole Brain Butyrate PET Radiotracer Binding', 'timeFrame': 'Pre and Post approximately 30 days of intervention', 'description': 'Whole-brain butyrate distribution volume ratios (DVRs) were computed relative to a cerebral white matter reference region pre and post approximately 30 days of open-label treatment with tributyrin. Lower radiotracer binding is interpreted to reflect higher levels of (non-tracer) butyrate in the brain, whereas higher radiotracer binding reflects higher butyrate receptor binding site availability, indicating lower levels of non-tracer butyrate in the brain.'}, {'measure': 'Glucose Metabolism', 'timeFrame': 'Pre and Post approximately 30 days of intervention', 'description': 'Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the SCFA prodrug tributyrin in patients with PD and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL withing 2 hours of eating meals.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['short chain fatty acid', 'butyrate', 'tributyrin', 'functional neuroimaging'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Small exploratory open-label pilot study to assess the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease', 'detailedDescription': 'The overarching goal of this small exploratory open-label pilot study is to explore metabolic (glucose metabolism, butyrate) and cognition (MoCa) before and after open-label treatment with the short-chain fatty acid (SCFA) prodrug tributyrin in a small pilot study in PD and normal control older adults. Positive findings in this small exploratory pilot trial may support target engagement study of SCFA supplementation in normal adults and PD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy control volunteers over 45 years of age\n* People with Parkinson Disease over 45 years of age\n\nExclusion Criteria:\n\n* Subjects with contra-indications to MR imaging, including pacemakers or claustrophobia;\n* Evidence of large vessel stroke or mass lesion on MRI\n* Regular use of anti-cholinergic, benzodiazepines or neuroleptic drugs\n* History of significant GI disease\n* Significant metabolic or uncontrolled medical comorbidity\n* Poorly controlled diabetes\n* Pregnancy or breast feeding\n* Dementia requiring informed assent\n* Suicidal ideation'}, 'identificationModule': {'nctId': 'NCT05446168', 'acronym': 'BUTTER', 'briefTitle': 'Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation', 'orgStudyIdInfo': {'id': 'HUM00211320'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Parkinson's Disease Tributyrin Intervention", 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.', 'interventionNames': ['Drug: tributyrin']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Control Tributyrin Intervention', 'description': 'Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.', 'interventionNames': ['Drug: tributyrin']}], 'interventions': [{'name': 'tributyrin', 'type': 'DRUG', 'description': 'Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days.', 'armGroupLabels': ['Healthy Control Tributyrin Intervention', "Parkinson's Disease Tributyrin Intervention"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Nicolaas I Bohnen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicolaas Bohnen, MD, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Nicolaas Bohnen, MD, PhD', 'investigatorAffiliation': 'University of Michigan'}}}}