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Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01536769
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : November 15, 2016
Sponsor:
Collaborators:
Jorvi Hospital
Hyvinkää Hospital
Peijas Hospital
University of Helsinki
Information provided by (Responsible Party):
Filip Scheperjans, Helsinki University Central Hospital

Study Description
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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.


Condition or disease
Parkinson's Disease

Study Design
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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease
Study Start Date : November 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Biospecimen Retention:   Samples With DNA
Nasal and oral bacterial swabs and stool samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospital patients in- and outpatient From the community
Criteria

Inclusion Criteria:

  • over 50 years of age

Exclusion Criteria:

  • Active smoking
  • relevant gastrointestinal or ENT disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536769


Locations
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Finland
Jorvi Hospital
Espoo, Finland
Helsinki University Central Hospital
Helsinki, Finland, 00290
Institute of Biotechnology, Helsinki University
Helsinki, Finland
Hyvinkää Hospital
Hyvinkää, Finland
Peijas Hospital
Vantaa, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Jorvi Hospital
Hyvinkää Hospital
Peijas Hospital
University of Helsinki
Investigators
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Principal Investigator: Filip Scheperjans, MD, PhD Helsinki University Central Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Filip Scheperjans, Neurologist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01536769    
Other Study ID Numbers: 86/2011
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Keywords provided by Filip Scheperjans, Helsinki University Central Hospital:
Metagenomic analysis
Microbiota
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases