Helicobacter Pylori Eradication Study in Parkinson's Disease - Full Text View

Purpose

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).

Condition	Intervention
Parkinson's Disease Helicobacter Pylori Infection	Drug: Helicobacter pylori eradication therapy Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by University of Malaya:

Primary Outcome Measures:

"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 Outcome Measures:

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 ]


Estimated Enrollment:	78
Study Start Date:	December 2013
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Helicobacter pylori eradication therapy Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD	Drug: Helicobacter pylori eradication therapy
Placebo Comparator: Placebo Maltodextrin	Drug: Placebo

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged ≥18 years
Provision of written informed consent
Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist

Exclusion Criteria:

History of previous gastric or major abdominal/pelvic surgery
History of previous eradication therapy for Helicobacter pylori
Antibiotic use in the preceding four weeks or use of anti-acid/prokinetics/laxatives in the preceding one week prior to breath test
Recent initiation of dopaminergic medications (within the last three months) or recent adjustment of dopaminergic medications (within the last one month)
History of functional neurosurgery for PD
No concomitant neurologic disease except PD
Medical condition that prevents reliable completion of questionnaire

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02108704

Locations


Malaysia
University of Malaya
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100

Sponsors and Collaborators

University of Malaya

More Information


Responsible Party:	University of Malaya
ClinicalTrials.gov Identifier:	NCT02108704 History of Changes
Other Study ID Numbers:	HPPD
Study First Received:	April 4, 2014
Last Updated:	December 10, 2015

Keywords provided by University of Malaya:


Parkinson's Disease Helicobacter pylori infection

Additional relevant MeSH terms:


Parkinson Disease Helicobacter Infections Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases	Nervous System Diseases Movement Disorders Neurodegenerative Diseases Gram-Negative Bacterial Infections Bacterial Infections

ClinicalTrials.gov processed this record on July 11, 2017