Overview

This trial is active, not recruiting.

Conditions parkinson's disease, helicobacter pylori infection
Treatments helicobacter pylori eradication therapy, placebo
Sponsor University of Malaya
Start date December 2013
End date December 2015
Trial size 78 participants
Trial identifier NCT02108704, HPPD

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), 72 hour Diary, Leeds Dyspepsia Questionnaire (LDQ), Parkinson's Disease Questionnaire (PDQ-39), UPDRS Part I, Part II and Part IV; and Montreal Cognitive Assessment (MOCA).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD
helicobacter pylori eradication therapy
(Placebo Comparator)
Maltodextrin
placebo

Primary Outcomes

Measure
"On-medication" UPDRS Part III score
time frame: at 3 months after randomisation
"On-medication" Pegboard Score
time frame: at 3 months after randomisation
"On-medication" Timed Gait Score
time frame: at 3 months after randomisation
"On-medication" UPDRS Part III score
time frame: at 1 year post randomisation
"On-medication" Pegboard Score
time frame: at 1 year post randomisation
"On-medication" Timed Gait Score
time frame: at 1 year post randomisation

Secondary Outcomes

Measure
Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores
time frame: at 3 months and 1 year post randomisation
Leeds Dyspepsia Questionnaire
time frame: at 3 months and 1 year post randomisation
Parkinson Disease Questionnaire (PDQ-39)
time frame: at 3 months and 1 year post randomisation
UPDRS Part I
time frame: at 3 months and 1 year post randomisation
UPDRS Part II
time frame: at 3 months and 1 year post randomisation
UPDRS Part IV
time frame: at 3 months and 1 year post randomisation
Montreal Cognitive Assessment Score
time frame: at 3 months and 1 year post randomisation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Malaya.