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

NCT ID: NCT01536769

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Keywords

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Metagenomic analysis Microbiota

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson patients

Parkinson patients, symptom onset \> 50 years of age, non-smoker, no relevant gastrointestinal or ENT diseases

No interventions assigned to this group

Control subjects

No parkinsonism, age and gender matched to PD subjects, non-smoker, no relevant gastrointestinal or ENT diseases

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* over 50 years of age

Exclusion Criteria

* Active smoking
* relevant gastrointestinal or ENT disease
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jorvi Hospital

UNKNOWN

Sponsor Role collaborator

Hyvinkää Hospital

OTHER

Sponsor Role collaborator

Peijas Hospital

UNKNOWN

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Filip Scheperjans

Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip Scheperjans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Jorvi Hospital

Espoo, , Finland

Site Status

Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Institute of Biotechnology, Helsinki University

Helsinki, , Finland

Site Status

Hyvinkää Hospital

Hyvinkää, , Finland

Site Status

Peijas Hospital

Vantaa, , Finland

Site Status

Countries

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Finland

Other Identifiers

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86/2011

Identifier Type: -

Identifier Source: org_study_id