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

February 16, 2012
January 28, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01536769 on ClinicalTrials.gov Archive Site
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Not Provided
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Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease
Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Nasal and oral bacterial swabs and stool samples

Non-Probability Sample

Hospital patients in- and outpatient From the community

Parkinson's Disease
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • over 50 years of age

Exclusion Criteria:

  • Active smoking
  • relevant gastrointestinal or ENT disease
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01536769
86/2011
No
Filip Scheperjans, Helsinki University Central Hospital
Helsinki University Central Hospital
  • Jorvi Hospital
  • Hyvinkää Hospital
  • Peijas Hospital
  • Helsinki University
Principal Investigator: Filip Scheperjans, MD, PhD Helsinki University Central Hospital
Helsinki University Central Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP