NCT02108704

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

April 4, 2014

Last Update Submit

October 28, 2019

Conditions

Parkinson's DiseaseHelicobacter Pylori Infection

Keywords

Parkinson's DiseaseHelicobacter pylori infection

Outcome Measures

Primary Outcomes (1)

  • "On-medication" MDS-UPDRS Part III score

    at 3 months after randomisation

Secondary Outcomes (10)

  • "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

  • +5 more secondary outcomes

Study Arms (2)

Helicobacter pylori eradication therapy

ACTIVE COMPARATOR

Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD

Drug: Helicobacter pylori eradication therapy

Placebo

PLACEBO COMPARATOR

Maltodextrin

Drug: Placebo

Interventions

Helicobacter pylori eradication therapyDRUG
Helicobacter pylori eradication therapy
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ai Huey Tan, MD,MRCP(UK)

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 9, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations

MY(1)