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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Jorvi Hospital
Hyvinkää Hospital
Peijas Hospital
Helsinki University
Information provided by (Responsible Party):
Filip Scheperjans, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01536769
First received: February 16, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Biospecimen Retention:   Samples With DNA

Nasal and oral bacterial swabs and stool samples


Enrollment: 150
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536769

Locations
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
Helsinki University
Investigators
Principal Investigator: Filip Scheperjans, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Filip Scheperjans, Neurologist, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01536769     History of Changes
Other Study ID Numbers: 86/2011
Study First Received: February 16, 2012
Last Updated: January 28, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:
Metagenomic analysis
Microbiota

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 29, 2014