Clinical trial NCT02108704: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Helicobacter Pylori Infection
Keywords: Parkinson's Disease
Helicobacter pylori infection
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: "On-medication" MDS-UPDRS Part III score
timeFrame: at 3 months after randomisation
Secondary outcomes:
measure: "On-medication" UPDRS Part III score
timeFrame: at 1 year post randomisation
measure: "On-medication" Pegboard Score
timeFrame: at 3 months and 1 year post randomisation
measure: "On-medication" Timed Gait Score
timeFrame: at 3 months and 1 year post randomisation
measure: Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores
timeFrame: at 3 months and 1 year post randomisation
measure: UPDRS Part IV
timeFrame: at 3 months and 1 year post randomisation
measure: UPDRS Part II
timeFrame: at 3 months and 1 year post randomisation
measure: UPDRS Part I
timeFrame: at 3 months and 1 year post randomisation
measure: Montreal Cognitive Assessment Score
timeFrame: at 3 months and 1 year post randomisation
measure: Leeds Dyspepsia Questionnaire
timeFrame: at 3 months and 1 year post randomisation
measure: Parkinson Disease Questionnaire (PDQ-39)
timeFrame: at 3 months and 1 year post randomisation
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Ai Huey Tan, MD,MRCP(UK)
role: PRINCIPAL_INVESTIGATOR
References: