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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helicobacter pylori eradication therapy | Active Comparator | Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD |
|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helicobacter pylori eradication therapy | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| "On-medication" MDS-UPDRS Part III score | at 3 months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| "On-medication" UPDRS Part III score | at 1 year post randomisation | |
| "On-medication" Pegboard Score | at 3 months and 1 year post randomisation | |
| "On-medication" Timed Gait Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ai Huey Tan, MD,MRCP(UK) | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Drug |
|
| at 3 months and 1 year post randomisation |
| Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores | at 3 months and 1 year post randomisation |
| UPDRS Part IV | at 3 months and 1 year post randomisation |
| UPDRS Part II | at 3 months and 1 year post randomisation |
| UPDRS Part I | at 3 months and 1 year post randomisation |
| Montreal Cognitive Assessment Score | at 3 months and 1 year post randomisation |
| Leeds Dyspepsia Questionnaire | at 3 months and 1 year post randomisation |
| Parkinson Disease Questionnaire (PDQ-39) | at 3 months and 1 year post randomisation |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |