Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-14 @ 12:08 AM
Study NCT ID:
NCT06762028
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change of Part 3 score of the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) on L-dopa challenge test", 'timeFrame': 'Same day of study visit', 'description': 'The primary outcome is the acute responsiveness to an immediate release L-dopa/carbidopa or L-dopa/benserazide dose, quantified as the percent change from pre-intake ("OFF" state) to full "ON" state of the Part 3 score of the MDS-Unified Parkinson\'s Disease Rating Scale (MDS-UPDRS).'}], 'secondaryOutcomes': [{'measure': 'time latency to full "ON" state', 'timeFrame': 'Same day of study visit', 'description': 'Temporal period between L-dopa ingestion and full "ON" state during a single L-dopa challenge test'}, {'measure': 'Part 4 score of the MDS-UPDRS', 'timeFrame': 'Same day of study visit', 'description': 'Motor fluctuations and L-dopa-induced dyskinesia'}, {'measure': 'Maximum observed plasma concentration of L-dopa (Cmax)', 'timeFrame': 'Same day of study visit', 'description': 'The investigators will determine maximum observed plasma concentration (Cmax) directly from serial samples.'}, {'measure': 'Time to maximum observed plasma concentration (Tmax)', 'timeFrame': 'Same day of study visit', 'description': 'The investigators will determine time to maximum observed plasma concentration (Tmax) directly from serial samples.'}, {'measure': 'Area under the L-dopa concentration-time curve (0-3 hours; AUC0-3 h)', 'timeFrame': 'Same day as study visit', 'description': 'The investigators will determine the area under the L-dopa plasma concentration-time curve (0-3 hours; AUC0-3 h).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SIMBA', 'small intestine', 'L-dopa'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The investigators hypothesize that small intestinal (SI) microbiome biomarkers predict the responsiveness to oral levodopa/carbidopa in people with Parkinson's disease (PwPD). The investigators will analyze the bacterial species and function of bacterial pathways influencing the responsiveness of PwPD to oral L-dopa. The investigators will pursue this goal using a reliable capsule system (SIMBA capsule, Nimble Science, Calgary, AB) that suitably captures SI luminal fluid for multi-omics analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with Parkinson disease fulfilling section criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females aged 50-85 years old at time of on-site visit. (ages 81-85 will be assessed on a per case basis by the principal investigator)\n2. Signed Informed consent.\n3. Willing \\& able to comply with study procedures (including SIMBA capsule ingestion) and have study assessments performed.\n4. Able to swallow a size-00 capsule (25mm length) in OFF state.\n5. Diagnosis of idiopathic PD (Clinically Probable PD), including documented levodopa responsiveness.\n6. Treatment with an immediate release levodopa formulation during the day at a stable dose for at least 2 months prior to enrollment.\n\nExclusion Criteria:\n\n1. Any risk of capsule non-excretion related to intercurrent gastrointestinal conditions.\n2. Use of any medications in the week prior to the on-site study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function.\n3. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g., SDQ score \\> 4.\n4. Any concomitant or previous treatment (\\<2 months from on-site study visit) with significant anti-inflammatory or immune suppressant medication, e.g., DMARDs, biologicals or systemic corticosteroids, except non-chronic PRN use of an NSAID and/or 5-ASA (mesalazine) treatment.\n5. Active cancer within 5 years.\n6. Clinically significant immune deficiency (according to Investigator's judgement).\n7. Antibiotic use (except for local use), ≤12 weeks prior to on-site study visit, or Fecal Microbiota Transplantation anytime in medical history.\n8. Use of prebiotics, or probiotics ≤2 weeks prior to the on-site study visit.\n9. Dementia in medical history.\n10. Insulin-dependent diabetes mellitus.\n11. Current Psychosis episode by clinical judgement based on anamnesis.\n12. Pregnancy.\n13. Alcohol or drug abuse.\n14. Deep brain stimulation or Duodopa/Lecigon treatment."}, 'identificationModule': {'nctId': 'NCT06762028', 'acronym': 'LENSER', 'briefTitle': "Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': "Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'UCalgaryREB24-1779'}, 'secondaryIdInfos': [{'id': 'POP24-11461', 'type': 'OTHER_GRANT', 'domain': 'Weston Family Foundation'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SIMBA capsule', 'type': 'DEVICE', 'description': 'The small intestine microbiome aspiration (SIMBA) system is a single-use, ingestible passive capsule that allows for the non-invasive sampling of small intestinal contents. It is designed to open and adsorb intestinal content after having passed the acid stomach environment and to close mechanically before passing into the large bowel. It has distinct markers built in to allow radiographic tracking of its passage throughout the GI system.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Davide Martino', 'role': 'CONTACT', 'email': 'davide.martino@ucalgary.ca', 'phone': '4032108726'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}