Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-01 @ 1:31 PM
Study NCT ID:
NCT02108704
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Pylori Eradication Study 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-28', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-08', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"On-medication" MDS-UPDRS Part III score', 'timeFrame': 'at 3 months after randomisation'}], 'secondaryOutcomes': [{'measure': '"On-medication" UPDRS Part III score', 'timeFrame': 'at 1 year post randomisation'}, {'measure': '"On-medication" Pegboard Score', 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': '"On-medication" Timed Gait Score', 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': "Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores", 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': 'UPDRS Part IV', 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': 'UPDRS Part II', 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': 'UPDRS Part I', 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': 'Montreal Cognitive Assessment Score', 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': 'Leeds Dyspepsia Questionnaire', 'timeFrame': 'at 3 months and 1 year post randomisation'}, {'measure': 'Parkinson Disease Questionnaire (PDQ-39)', 'timeFrame': 'at 3 months and 1 year post randomisation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Helicobacter pylori infection'], 'conditions': ["Parkinson's Disease", 'Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'It has been hypothesized, based on epidemiological observations, that Helicobacter pylori (HP) infection may play a role in the pathogenesis of Parkinson\'s Disease (PD). Previous studies have also shown that HP eradication therapy may result in improvements in levodopa pharmacokinetics and motor fluctuations. This study aims to examine the effects of HP eradication, using a double-blind randomized placebo-controlled trial design in a relatively large cohort of patients. Outcomes of interest include motor function, gastrointestinal symptoms and health-related quality of life. The investigators hypothesize that HP eradication will lead to improvements in motor function. The primary outcome of interest is the "ON"-medication Unified PD Rating Scale (UPDRS) Part III score at 3 months. Secondary outcomes include Purdue Pegboard Score, Timed Test of Gait, Dyskinesia and Bradykinesia scores measured by Parkinson\'s Kinetigraph (PKG), Leeds Dyspepsia Questionnaire (LDQ), Parkinson\'s Disease Questionnaire (PDQ-39), UPDRS Part I, Part II and Part IV; and Montreal Cognitive Assessment (MOCA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged ≥18 years\n2. Provision of written informed consent\n3. Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist\n\nExclusion Criteria:\n\n1. History of previous gastric or major abdominal/pelvic surgery\n2. History of previous eradication therapy for Helicobacter pylori\n3. Antibiotic use in the preceding four weeks or use of anti-acid/prokinetics/laxatives in the preceding one week prior to breath test\n4. Recent initiation of dopaminergic medications (within the last three months) or recent adjustment of dopaminergic medications (within the last one month)\n5. History of functional neurosurgery for PD\n6. No concomitant neurologic disease except PD\n7. Medical condition that prevents reliable completion of questionnaire"}, 'identificationModule': {'nctId': 'NCT02108704', 'briefTitle': "Helicobacter Pylori Eradication Study in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': "Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial", 'orgStudyIdInfo': {'id': 'HPPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Helicobacter pylori eradication therapy', 'description': 'Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD', 'interventionNames': ['Drug: Helicobacter pylori eradication therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maltodextrin', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Helicobacter pylori eradication therapy', 'type': 'DRUG', 'armGroupLabels': ['Helicobacter pylori eradication therapy']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University of Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Ai Huey Tan, MD,MRCP(UK)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}