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Completed

NCT Number: NCT02108704

Helicobacter Pylori Eradication Study in Parkinson's Disease

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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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Helicobacter Pylori Infection Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya

Kuala Lumpur, 59100, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Helicobacter pylori eradication therapy

Drug

Placebo

Drug

Primary outcomes

  1. "On-medication" MDS-UPDRS Part III score

    Time frame: at 3 months after randomisation

Secondary outcomes

  1. "On-medication" UPDRS Part III score

    Time frame: at 1 year post randomisation

  2. "On-medication" Pegboard Score

    Time frame: at 3 months and 1 year post randomisation

  3. "On-medication" Timed Gait Score

    Time frame: at 3 months and 1 year post randomisation

  4. Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores

    Time frame: at 3 months and 1 year post randomisation

  5. UPDRS Part IV

    Time frame: at 3 months and 1 year post randomisation

  6. UPDRS Part II

    Time frame: at 3 months and 1 year post randomisation

  7. UPDRS Part I

    Time frame: at 3 months and 1 year post randomisation

  8. Montreal Cognitive Assessment Score

    Time frame: at 3 months and 1 year post randomisation

  9. Leeds Dyspepsia Questionnaire

    Time frame: at 3 months and 1 year post randomisation

  10. Parkinson Disease Questionnaire (PDQ-39)

    Time frame: at 3 months and 1 year post randomisation

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 9, 2014
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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