Helicobacter Pylori Eradication Study in Parkinson's Disease

NCT ID: NCT02108704

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-05-31

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).

Conditions

Parkinson's Disease; Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Helicobacter pylori eradication therapy

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

Group Type: ACTIVE_COMPARATOR

Helicobacter pylori eradication therapy

Intervention Type: DRUG

Placebo

Maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Helicobacter pylori eradication therapy

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ai Huey Tan, MD,MRCP(UK)

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

University of Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Other Identifiers

HPPD

Identifier Type: -

Identifier Source: org_study_id