Parkinson's DiseaseNCT02108704
Helicobacter Pylori Eradication Study in Parkinson's Disease
A study testing Helicobacter pylori eradication therapy in people with Parkinson's Disease and Helicobacter Pylori Infection, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Helicobacter Pylori Infection
- What is being tested?
- Helicobacter pylori eradication therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2013to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Provision of written informed consent
- Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial
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).
- Conditions
- Parkinson's Disease, Helicobacter Pylori Infection
- Being tested
- Helicobacter pylori eradication therapy, Placebo
- Keywords
- Parkinson's Disease, Helicobacter pylori infection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicobacter pylori eradication therapyDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Helicobacter pylori eradication therapy | Active comparator | Amoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD Receives: Drug: Helicobacter pylori eradication therapy |
| Placebo | Placebo comparator | Maltodextrin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
"On-medication" MDS-UPDRS Part III score
Measured: at 3 months after randomisation
Secondary outcomes (10)
"On-medication" UPDRS Part III score
Measured: at 1 year post randomisation
"On-medication" Pegboard Score
Measured: at 3 months and 1 year post randomisation
"On-medication" Timed Gait Score
Measured: at 3 months and 1 year post randomisation
Parkinson's Kinetigraph (PKG) Bradykinesia and Dyskinesia Scores
Measured: at 3 months and 1 year post randomisation
UPDRS Part IV
Measured: at 3 months and 1 year post randomisation
UPDRS Part II
Measured: at 3 months and 1 year post randomisation
UPDRS Part I
Measured: at 3 months and 1 year post randomisation
Montreal Cognitive Assessment Score
Measured: at 3 months and 1 year post randomisation
Leeds Dyspepsia Questionnaire
Measured: at 3 months and 1 year post randomisation
Parkinson Disease Questionnaire (PDQ-39)
Measured: at 3 months and 1 year post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ai Huey Tan, MD,MRCP(UK), Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108704
- Sponsor's protocol ID
- HPPD
- Status last verified
- Oct 2019
- First submitted
- 4 Apr 2014
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02108704
- Acronym / sponsor ID
- HPPD
- Conditions
- Parkinson's Disease, Helicobacter Pylori Infection
- Keywords
- Parkinson's Disease, Helicobacter pylori infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helicobacter pylori eradication therapy | Active comparator | Drug: Helicobacter pylori eradication therapyAmoxycillin 1gm twice a day (BD) Clarithromycin 500mg BD Omeprazole 20mg BD |
| Placebo | Placebo comparator | Drug: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years
- Provision of written informed consent
- Clinical diagnosis of Parkinson's Disease (PD) assigned by a consultant neurologist
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helicobacter pylori eradication therapy | Drug | Helicobacter pylori eradication therapy |
| Placebo | Drug | Placebo |
Primary outcome
"On-medication" MDS-UPDRS Part III score
Time frame: at 3 months after randomisation
10 secondary outcomes
"On-medication" UPDRS Part III score
Time frame: at 1 year post randomisation
"On-medication" Pegboard Score
Time frame: at 3 months and 1 year post randomisation
"On-medication" Timed Gait 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 IV
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 I
Time frame: at 3 months and 1 year post randomisation
Montreal Cognitive Assessment Score
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ai Huey Tan, MD,MRCP(UK) principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helicobacter pylori eradication therapy in people with Parkinson's Disease and Helicobacter Pylori Infection, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"On-medication" MDS-UPDRS Part III score (time frame: at 3 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.