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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02108704
Date of registration:	04/04/2014
Prospective Registration:	No
Primary sponsor:	University of Malaya
Public title:	Helicobacter Pylori Eradication Study in Parkinson's Disease
Scientific title:	Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial
Date of first enrolment:	December 2013
Target sample size:	75
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02108704
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Malaysia

Contacts

Name:	Ai Huey Tan, MD,MRCP(UK)
Address:
Telephone:
Email:
Affiliation:	University of Malaya

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Helicobacter Pylori Infection

Parkinson's Disease

Intervention(s)

Drug: Helicobacter pylori eradication therapy

Drug: Placebo

Primary Outcome(s)

"On-medication" MDS-UPDRS Part III score [Time Frame: at 3 months after randomisation]

Secondary Outcome(s)

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]

"On-medication" UPDRS Part III score [Time Frame: at 1 year post randomisation]

"On-medication" Timed Gait Score [Time Frame: at 3 months and 1 year post randomisation]

Montreal Cognitive Assessment Score [Time Frame: at 3 months and 1 year post randomisation]

Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores [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]

"On-medication" Pegboard Score [Time Frame: at 3 months and 1 year post randomisation]

Leeds Dyspepsia Questionnaire [Time Frame: at 3 months and 1 year post randomisation]

Secondary ID(s)

HPPD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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