Helicobacter Pylori Eradication Study in Parkinson's Disease
Primary Purpose
Parkinson's Disease, Helicobacter Pylori Infection
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Helicobacter pylori eradication therapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Helicobacter pylori infection
Eligibility Criteria
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
Sites / Locations
- University of Malaya
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Helicobacter pylori eradication therapy
Placebo
Arm Description
Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD
Maltodextrin
Outcomes
Primary Outcome Measures
"On-medication" MDS-UPDRS Part III score
Secondary Outcome Measures
"On-medication" UPDRS Part III score
"On-medication" Pegboard Score
"On-medication" Timed Gait Score
Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores
UPDRS Part IV
UPDRS Part II
UPDRS Part I
Montreal Cognitive Assessment Score
Leeds Dyspepsia Questionnaire
Parkinson Disease Questionnaire (PDQ-39)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02108704
Brief Title
Helicobacter Pylori Eradication Study in Parkinson's Disease
Official Title
Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Helicobacter Pylori Infection
Keywords
Parkinson's Disease, Helicobacter pylori infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Helicobacter pylori eradication therapy
Arm Type
Active Comparator
Arm Description
Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Drug
Intervention Name(s)
Helicobacter pylori eradication therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
"On-medication" MDS-UPDRS Part III score
Time Frame
at 3 months after randomisation
Secondary Outcome Measure Information:
Title
"On-medication" UPDRS Part III score
Time Frame
at 1 year post randomisation
Title
"On-medication" Pegboard Score
Time Frame
at 3 months and 1 year post randomisation
Title
"On-medication" Timed Gait Score
Time Frame
at 3 months and 1 year post randomisation
Title
Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores
Time Frame
at 3 months and 1 year post randomisation
Title
UPDRS Part IV
Time Frame
at 3 months and 1 year post randomisation
Title
UPDRS Part II
Time Frame
at 3 months and 1 year post randomisation
Title
UPDRS Part I
Time Frame
at 3 months and 1 year post randomisation
Title
Montreal Cognitive Assessment Score
Time Frame
at 3 months and 1 year post randomisation
Title
Leeds Dyspepsia Questionnaire
Time Frame
at 3 months and 1 year post randomisation
Title
Parkinson Disease Questionnaire (PDQ-39)
Time Frame
at 3 months and 1 year post randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ai Huey Tan, MD,MRCP(UK)
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
12. IPD Sharing Statement
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Helicobacter Pylori Eradication Study in Parkinson's Disease
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