Helicobacter Pylori Eradication Study in Parkinson's Disease

Study Overview
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Brief Summary
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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).

Official Title
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Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial

Conditions
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Parkinson's Disease, Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Helicobacter pylori eradication therapy
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years Provision of written informed consent Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist Exclusion Criteria: History of previous gastric or major abdominal/pelvic surgery History of previous eradication therapy for Helicobacter pylori Antibiotic use in the preceding four weeks or use of anti-acid/prokinetics/laxatives in the preceding one week prior to breath test Recent initiation of dopaminergic medications (within the last three months) or recent adjustment of dopaminergic medications (within the last one month) History of functional neurosurgery for PD No concomitant neurologic disease except PD Medical condition that prevents reliable completion of questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Helicobacter pylori eradication therapy<br>Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD | Drug: Helicobacter pylori eradication therapy<br> <br> |
| Placebo Comparator: Placebo<br>Maltodextrin | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On-medication MDS-UPDRS Part III score |  | at 3 months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Helicobacter pylori infection