Effects of Helicobacter Pylori Infection Eradication in Patients With Parkinson's Disease

NCT02112812 | Completed

• 1 other identifier: FF0452012
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

A higher prevalence of Helicobacter pylori infection rate has been demonstrated among PD patients compared to controls. As H. pylori infection is known to interfere with levodopa absorption, we embarked on this is a study to understand the effects of Helicobacter pylori infection eradication among a selected Malaysian population with Parkinsons disease, in relation to levodopa effectiveness and motor improvements. The study hypotheses are:

1. 1.H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time' duration.
2. 2.PD patients with H. pylori infection show clinical improvement in motor disability and quality of life after eradication therapy of H. pylori, assessed using UPDRS-III / PDQ39 questionnaires.

Conditions

Response to Levodopa; Motor Outcomes; Quality of Life Outcomes

Keywords

Parkinsons disease; Helicobacter pylori; Eradication; Levodopa response; Motor outcomes; Quality of Life; Open label

Outcome Measures

Primary Outcomes (2)

• 1. H. pylori eradication improves L-dopa 'onset' time and prolongs the L-dopa 'on-time' duration.

  This was measured by asking the patient to determine the time taken to experience on from the time of ingestion of levodopa and to determine the duration of time that they are ON, while receiving levodopa. The patients are asked to keep a diary if possible. If not, the patients are asked during their visits, baseline visit, visit 1, visit 2 and visit 3

  3months

• Improvement in L-dopa 'onset' time and L-dopa 'on-time' duration following H.pylori eradication

  Patients are followed up every 4 weeks, for 12 weeks ( 3 visits). The levodopa onset time is calculated based on the time taken to achieve on following levodopa ingestion, while the ON-time duration is the time the patient remains on following levodopa ingestion. Patients are asked to keep a diary, if possible.

  3 months post eradication

Secondary Outcomes (1)

• Improvement in motor disability after eradication therapy of H. pylori, assessed using UPDRS-III , and improvement in quality of life using PDQ39

  3 months post eradication

Study Arms (1)

Eradication therapy

EXPERIMENTAL

The patients who were positive for H.pylori infection are entered into an eradication therapy protocol which includes oral esomeprazole 40mg daily, oral clarithromycin 500mg bd and oral amoxicillin 1000mg bd for 14 days.

Drug: Eradication therapy for H.pylori infection; Drug: Eradication of Helcobacter Pylori; Drug: Eradication therapy for Helicobacter pylori

Interventions

Eradication therapy for H.pylori infection DRUG

Patients who were positive for H.pylori infection received an eradication therapy consisting of oral esomeprazole 40 md daily, oral clarithromycin 500mg bd and oral amoxicillin 1000mg bd for 14 days.

Eradication therapy

Eradication of Helcobacter Pylori DRUG

Patients who are positive on urea breath test are given eradication therapy for 14 days, Eradication therapy includes esomeprazole 40mg daily, clarithromycin 500mg bd, amoxicillin 1g bd

Eradication therapy

Eradication therapy for Helicobacter pylori DRUG

Eradication therapy

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease (PD) by a neurologist
• Age more than 18 years
• Written informed consent given either by the patient or next of kin
• Patient on L-DOPA therapy

You may not qualify if:

• Patients with a diagnosis of secondary parkinsonism, and Parkinson's plus syndrome
• History of recent proton pump inhibitors (PPIs) or Histamine (H2) antagonist use for at least 4 weeks prior to the urea breath test
• History of recent antibiotics use (less than 6 months)
• Inability to perform urea breath test

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

UKM Medical Center

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

• Hashim H, Azmin S, Razlan H, Yahya NW, Tan HJ, Manaf MR, Ibrahim NM. Eradication of Helicobacter pylori infection improves levodopa action, clinical symptoms and quality of life in patients with Parkinson's disease. PLoS One. 2014 Nov 20;9(11):e112330. doi: 10.1371/journal.pone.0112330. eCollection 2014.

  PMID: 25411976 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Norlinah Mohamed Ibrahim, MBBCH, MRCP

  Department of Medicine, Faculty of Medicine, National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Datin

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: December 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 14, 2014

Record last verified: 2014-04

Locations

MY (1)