drugset / Trial / NCT02108704

Helicobacter Pylori Eradication Study in Parkinson's Disease

NCT02108704

Completed 75 enrolled University of Malaya
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2013-12
Primary completion
2015-12
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 1 g
Comparator Clarithromycin Small molecule 500 mg
Comparator Omeprazole Other / unclassified 20 mg