Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease
1 other identifier
observational
150
1 country
5
Brief Summary
The cause of Parkinson's disease (PD) is unknown and a reliable biomarker to identify PD patients as early as possible is urgently needed. Nerve cells near the nose and in the gut become first affected in PD and patients frequently suffer from loss of smell and constipation. The nose and gut harbor very high amounts of bacteria that influence our body functions in many ways, even in the brain. The investigators are examining a possible role of bacteria of the nose and gut in the pathogenesis of PD. This may lead to a better understanding of what PD causes and may open new possibilities for diagnosis and treatment. The investigators will recruit 100 PD patients and 100 control subjects. The investigators will characterize all subjects carefully with respect to clinical symptoms. The investigators will collect bacterial samples from the nose, mouth and stool of these subjects. Using modern genomic techniques the investigators will read out the genetic code of all bacteria contained in these samples and will be able to identify which species of bacteria are present in the samples. Using complex cluster computing the investigators will compare the pattern of bacterial species between PD patients and controls and look for specific abnormalities in PD patients. If the investigators can detect specific differences of bacterial communities between PD patients and controls this may point to a role of bacteria as a cause of PD. Since there are many ways to influence bacterial communities pharmacologically (antibiotics, probiotics) it will be possible to investigate whether these therapies could alleviate or even reverse PD symptoms. Furthermore, the investigators would be able to use these differences as a biomarker which would enable us to develop a quick screening test for bacterial samples that may reveal whether a person has PD or not. By doing this study the investigators will learn whether bacteria play a role in the development of PD and whether the investigators can use them as a biomarker or therapeutic target. So hopefully the investigators will be able in the future to better understand what causes PD, how the investigators can diagnose it as early as possible and how to cure patients from PD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2011
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 15, 2016
November 1, 2016
3.4 years
February 16, 2012
November 11, 2016
Conditions
Keywords
Study Arms (2)
Parkinson patients
Parkinson patients, symptom onset \> 50 years of age, non-smoker, no relevant gastrointestinal or ENT diseases
Control subjects
No parkinsonism, age and gender matched to PD subjects, non-smoker, no relevant gastrointestinal or ENT diseases
Eligibility Criteria
Hospital patients in- and outpatient From the community
You may qualify if:
- over 50 years of age
You may not qualify if:
- Active smoking
- relevant gastrointestinal or ENT disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Jorvi Hospitalcollaborator
- Hyvinkää Hospitalcollaborator
- Peijas Hospitalcollaborator
- University of Helsinkicollaborator
Study Sites (5)
Jorvi Hospital
Espoo, Finland
Helsinki University Central Hospital
Helsinki, 00290, Finland
Institute of Biotechnology, Helsinki University
Helsinki, Finland
Hyvinkää Hospital
Hyvinkää, Finland
Peijas Hospital
Vantaa, Finland
Biospecimen
Nasal and oral bacterial swabs and stool samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Filip Scheperjans, MD, PhD
Helsinki University Central Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurologist
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
November 1, 2011
Primary Completion
April 1, 2015
Study Completion
December 1, 2015
Last Updated
November 15, 2016
Record last verified: 2016-11