Helicobacter Pylori Eradication Study in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson's Disease; Helicobacter Pylori Infection
• Interventions: Drug: Helicobacter pylori eradication therapy; Drug: Placebo

• Registration Number: NCT02108704
• Lead Sponsor: University of Malaya

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helicobacter pylori eradication therapy	Helicobacter pylori eradication therapy	Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD
Placebo	Placebo	Maltodextrin

Primary Outcome Measures

Name	Time	Method
"On-medication" MDS-UPDRS Part III score	at 3 months after randomisation

Secondary Outcome Measures

Name	Time	Method
"On-medication" UPDRS Part III score	at 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
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
UPDRS Part I	at 3 months and 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

Trial Locations

Locations (1)

University of Malaya; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia