Treating H. Pylori in Parkinson's Patients With Motor Fluctuations

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment of H. pylori (an infection of the stomach) improves treatment effectiveness in patients with Parkinson's disease and motor fluctuations.

Detailed Description
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Previous investigations have demonstrated that treatment of Helicobacter pylori with antibiotics leads to improved absorption and pharmacokinetics of levodopa. This may potentially benefit patients with Parkinson's disease who have motor fluctuations, specifically excessive off time, when their levodopa is not working to control symptoms. We seek to identify the frequency of H. pylori infection in this population using standard lab assays and determine whether eradication with standard triple therapy results in improved clinical response to medication.

Official Title
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Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease

Conditions
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Parkinson's Disease, Helicobacter Infections, Motor Fluctuations

Intervention / Treatment
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* Drug: clartihromycin, amoxicillin, and omeprazole
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adults diagnosed with idiopathic Parkinson's disease, Hoehn & Yahr stage 2-4 in the off state, with no other concomitant neurologic diseases. Stable (≥30 days) Parkinson's disease therapy, with demonstrable medication efficacy, but with wearing off phenomenon present between levodopa doses (average off time ≥3 hours off time/day). Levodopa therapy required; Any formulation (e.g. Sinemet, Sinemet CR, Stalevo) is acceptable. Parkinson's disease treatment may also include any of the following medications or classes: non-ergot dopamine agonists, COMT inhibitors, MAO-B inhibitors, amantadine, anticholinergics. Positive for H. pylori IgG Ab by serum ELISA (before inclusion in randomized treatment arms). Exclusion criteria: Current abdominal pain, unexplained nausea/vomiting, or gastrointestinal bleeding. History of gastric cancer, peptic ulcer, duodenal ulcer, or other gastric or duodenal lesions. History of previous gastric surgery. History of previous brain surgery for Parkinson's disease. Family history of gastric cancer. Prior treatment for H. pylori+ status. Recent use (previous 4 weeks) of proton-pump inhibitor, amoxicillin, or clarithromycin. Allergy or sensitivity to penicillin, amoxicillin, clarithromycin, or omeprazole. Use of drugs affecting gastric motility (e.g. domperidone, metoclopramide). Inability to tolerate or participate in testing in the morning in an off state. Inability to communicate effectively with study personnel in English. Pregnancy.
Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Other: Active-placebo<br>These subject receive treatment with active triple therapy followed by treatment with placebo therapy. | Drug: clartihromycin, amoxicillin, and omeprazole<br>* clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days<br>* Other names: Biaxin, Prilosec;Drug: placebo<br>* placebo therapy<br>|
| Other: Placebo-active<br>These subject receive treatment with placebo therapy followed by treatment with active triple therapy. | Drug: clartihromycin, amoxicillin, and omeprazole<br>* clarithromycin 500mg - i PO BID x10 days; amoxicillin 1gm - i PO BID x10 days; omeprazole 10mg - i PO BID x10 days<br>* Other names: Biaxin, Prilosec;Drug: placebo<br>* placebo therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off Time | Average total daily off time (measured by patient symptom diaries) in hours | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in UPDRS Total Scores | The Unified Parkinson Disease Rating Scale (UPDRS) is a rating tool to follow the longitudinal course of Parkinson's Disease. It is made up of the 1) Mentation, Behavior, and Mood, 2) ADL and 3) Motor sections. These are evaluated by interview. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. 199 represents the worst (total) disability), 0--no disability. | 2 months | 
| Improvement in UDPRS Part III | Improvement in UDPRS Part III (Motor) scores (on and off) UPDRS III is the result of a motor examination with the scores 0-108. A decrease in the scores means improvement | 2 months | 
| Improvement in Quality of Life as Assessed by PDQ-39 | The Parkinson's Disease Questionnaire (PDQ)-39 contains 39 questions addressing how often patients have experienced difficulties due to having PD in the preceding month. Items are scored from 0 (never) to 4 (always). Lower scores indicate better quality of life. | 2 months | 
| Participants With Side Effects From Study Treatment | Side effects profile | 2 months | 

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