Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:24 AM
Study NCT ID:
NCT07418658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Untreated Parkinson's Disease Work-up Assessing Resident Microbiota and Duodenal Barrier Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Duodenal mucosal biopsy samples.\n2. A fecal sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paracellular flux', 'timeFrame': 'On day 7 (Follow-up visit)', 'description': 'After mounting duodenal mucosal biopsies on Ussing chambers, the paracellular permeability is measured by adding a fluorescently labelled dextran to the luminal side and quantifying cumulative paracellular flux to the basolateral side at serial time points.'}, {'measure': 'Transepithelial electrical resistance (TEER)', 'timeFrame': 'On day 7 (Follow-up visit)', 'description': 'After mounting duodenal mucosal biopsies on Ussing chambers, the TEER will be measured by applying an electrical current and recording the resulting change in potential difference (PD).'}, {'measure': 'Fecal microbiota composition', 'timeFrame': 'Analyses wil be performed after storage of stool samples, collected during the at-home phase (day 1-6) preceding the Follow-up visit on day 7.', 'description': 'The fecal microbiota composition will be analysed on fecal samples using techniques including (but not limited to) 16s rRNA sequencing.'}, {'measure': 'Duodenal microbiota composition', 'timeFrame': 'Analyses wil be performed after storage of duodenal samples, collected during the gastroduodenoscopy on day 7 (Follow-up visit).', 'description': 'The duodenal microbiota composition will be analysed on duodenal samples obtained by gastroduodenoscopy using techniques including (but not limited to) 16s rRNA sequencing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut Microbiome', 'Intestinal Permeability', 'Drug-Naïve'], 'conditions': ["Parkinson's Disease (PD)"]}, 'descriptionModule': {'briefSummary': "The UPWARD study is a prospective hypothesis-generating study in individuals with untreated Parkinson's disease (PD) and age-matched healthy controls (HCs). The objective of the study is to characterise disease-driven gastrointestinal (GI) changes that occur prior to initiation of treatment.\n\nThe main questions this study aims to answer are:\n\n1. Are there changes in duodenal permeability in people with untreated PD?\n2. Are there changes in the gut microbiome in people with untreated PD?\n3. Are these gut changes linked to prodromal features, or movement and non-movement symptoms of PD?\n\nThe study consists of a screening visit, followed by a six-day home phase and one subsequent study visit at UZ Leuven. During the home phase, participants collect a stool sample, ingest radiopaque markers to assess gut transit time, and complete questionnaires. During the study visit, participants undergo an abdominal X-ray, a clinical assessment, and blood sampling. An upper GI endoscopy with duodenal biopsies is offered as an optional component of the study.\n\nThis study does not test a therapeutic intervention. Examinations as part of the study are not standard clinical care. The findings are expected to improve understanding of early GI involvement in PD and to inform future mechanistic and clinical research.", 'detailedDescription': "This is a hypothesis-generating study aimed at characterising gut microbiome composition and intestinal permeability in patients with drug-naïve Parkinson's disease (PD), compared to age-matched healthy controls (HCs). Drug-naïve PD patients and HCs will be prospectively recruited. After a screening visit, participants will undergo a single study visit; no longitudinal follow-up is planned.\n\nParticipants will undergo standardized assessments across five domains: (1) gut microbiome and fecal read-outs, (2) duodenal barrier function assessed using optional duodenal biopsies, (3) whole-gut transit time measured with radiopaque markers, (4) clinical features assessed using validated questionnaires and rating scales, and (5) laboratory parameters obtained from blood sampling.\n\nFor the main study procedures (stool collection, radiopaque pellet ingestion with abdominal X-ray, clinical assessments, questionnaires, and blood sampling), approximately 75 drug-naïve PD patients will be included. Approximately one third are expected to consent to the optional gastroduodenoscopy, resulting in an estimated subgroup of 25 PD patients with duodenal biopsies. Age-matched healthy controls will be recruited in comparable numbers for the respective study components. All analyses will be cross-sectional."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient participants will be recruited during patient consultations in the Movement Disorders Clinic of UZ Leuven. Neurologists in other hospitals may also be informed about the study, so that they may refer interested patients to UZ Leuven for potential participation in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': "\\* Inclusion criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria:\n\n1. Diagnosis of Parkinson's Disease by a neurologist according to the Movement Disorder Society Clinical Diagnostic Criteria for PD\n2. Signed informed consent form\n3. Aged 18-75 years old\n4. Able to understand the study and questionnaires, and comply with study requirements\n\nControls eligible for inclusion in this study must meet all of the following criteria:\n\n1. Aged 40-75 years old\n2. Signed informed consent form\n3. Able to understand the study and questionnaires, and comply with study requirements\n\n * Exclusion criteria:\n\nParticipants eligible for this study must not meet any of the following criteria:\n\nPatients and controls:\n\n1. Gastrointestinal: diagnosis of organic gastrointestinal diseases potentially affecting the assessments during the study (e.g. inflammatory bowel disease (IBD), celiac disease, eosinophilic diseases of the gastro-intestinal tract, gastro-intestinal cancer, diverticulitis in the last 6 months, GI infection in the last 3 months, …).\n2. Surgery: major abdominal surgery (including, but not limited to: cholecystectomy, colectomy, hiatal hernia repair, …) except for uncomplicated appendectomy, splenectomy and inguinal hernia repair.\n3. Medication use:\n\n 1. Any previous exposure to medication used in the treatment of motor symptoms of Parkinson's disease (levodopa, dopamine agonists, MAO-B inhibitors, COMT-inhibitors, NMDA-receptor antagonists, anticholinergics)\n 2. Antibiotics use in the last 3 months.\n 3. Use of PPI in the last month.\n 4. Use of NSAID in the last month.\n 5. Use of anticoagulation4 (including vitamin K antagonists (VKA), direct oral anticoagulants (DOAC) or low-molecular weight heparins (LMWH)) or dual antiplatelet therapy4 (DUAPT; Acetylsalicilic acid (Asaflow®) + P2Y12-inhibitor (Clopidogrel®)).\n4. Pregnancy and breastfeeding.\n5. Other: Cancer and/or adjuvant treatment within the last 6 months\n6. Exposures:\n\n 1. Food intoxication in the last 3 months.\n 2. Consumptom of more than 2 standard units of alcohol per day.\n\nPatients (additional criteria)\n\n1\\. Neurological: any major neurological disorder other than Parkinson's disease.\n\nControls (additional criteria)\n\n1. Neurological:\n\n 1. A diagnosis of Parkinson's disease or any other major neurological disorder other than Parkinson's disease.\n 2. Clinical signs of parkinsonism.\n 3. First degree relative(s) with Parkinson's disease.\n2. Gastrointestinal: subjects fulfilling a clinical diagnosis of either Functional dyspepsia, Functional constipation, or Irritable bowel syndrome based on the ROME-IV diagnostic criteria."}, 'identificationModule': {'nctId': 'NCT07418658', 'acronym': 'UPWARD', 'briefTitle': "Untreated Parkinson's Disease Work-up Assessing Resident Microbiota and Duodenal Barrier Function", 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': "Multimodal Characterization of Gastrointestinal Structure, Function, and Microbiome in Drug-Naïve Parkinson's Disease", 'orgStudyIdInfo': {'id': 's71449'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Drug-Naïve Parkinson's disease patients", 'interventionNames': ['Other: Invasive sampling procedures', 'Other: Non-invasive sampling procedures']}, {'label': 'Age-matched healthy controls', 'interventionNames': ['Other: Invasive sampling procedures', 'Other: Non-invasive sampling procedures']}], 'interventions': [{'name': 'Invasive sampling procedures', 'type': 'OTHER', 'description': 'Invasive sampling procedures in the study include an (optional) gastroduodenoscopy with duodenal biopsies, and venous blood sampling.', 'armGroupLabels': ['Age-matched healthy controls', "Drug-Naïve Parkinson's disease patients"]}, {'name': 'Non-invasive sampling procedures', 'type': 'OTHER', 'description': 'Non-invasive sampling procedures in this study include a clinical examination, radiopaque pellet test with an abdominal X-ray (to assess whole-gut transit time), stool sample collection, and questionnaires.', 'armGroupLabels': ['Age-matched healthy controls', "Drug-Naïve Parkinson's disease patients"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'contacts': [{'name': 'Bo Konings, MD', 'role': 'CONTACT', 'email': 'bo.konings@uzleuven.be', 'phone': '+32494433087'}, {'name': 'Wim Vandenberghe, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}