Helicobacter Pylori Eradication Study in Parkinson's Disease

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Placebo; Drug: Helicobacter pylori eradication therapy

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
      • University of Malaya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged ≥18 years
2. Provision of written informed consent
3. Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist

Exclusion Criteria:

1. History of previous gastric or major abdominal/pelvic surgery
2. History of previous eradication therapy for Helicobacter pylori
3. Antibiotic use in the preceding four weeks or use of anti-acid/prokinetics/laxatives in the preceding one week prior to breath test
4. Recent initiation of dopaminergic medications (within the last three months) or recent adjustment of dopaminergic medications (within the last one month)
5. History of functional neurosurgery for PD
6. No concomitant neurologic disease except PD
7. Medical condition that prevents reliable completion of questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Ai Huey Tan, MD,MRCP(UK), University of Malaya

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Helicobacter pylori infection
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: HPPD