Helicobacter Pylori Eradication Study in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108704
• Other study ID #: HPPD
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 2016

Study information

• Verified date: October 2019
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Helicobacter pylori eradication therapy

• Placebo

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"On-medication" MDS-UPDRS Part III score		at 3 months after randomisation
Secondary	"On-medication" UPDRS Part III score		at 1 year post randomisation
Secondary	"On-medication" Pegboard Score		at 3 months and 1 year post randomisation
Secondary	"On-medication" Timed Gait Score		at 3 months and 1 year post randomisation
Secondary	Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores		at 3 months and 1 year post randomisation
Secondary	UPDRS Part IV		at 3 months and 1 year post randomisation
Secondary	UPDRS Part II		at 3 months and 1 year post randomisation
Secondary	UPDRS Part I		at 3 months and 1 year post randomisation
Secondary	Montreal Cognitive Assessment Score		at 3 months and 1 year post randomisation
Secondary	Leeds Dyspepsia Questionnaire		at 3 months and 1 year post randomisation
Secondary	Parkinson Disease Questionnaire (PDQ-39)		at 3 months and 1 year post randomisation