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

• ClinicalTrials.gov Identifier: NCT01536769
• Recruitment Status: Completed
• First Posted: February 22, 2012
• Last Update Posted: November 15, 2016
• Sponsor: Helsinki University Central Hospital
• Collaborators: Jorvi Hospital; Hyvinkää Hospital; Peijas Hospital; University of Helsinki
• Information provided by (Responsible Party): Filip Scheperjans, Helsinki University Central Hospital

Tracking Information

• First Submitted Date: February 16, 2012
• First Posted Date: February 22, 2012
• Last Update Posted Date: November 15, 2016
• Study Start Date: November 2011
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease
• Official Title: Intestinal and Nasal Microbiota of Patients With Idiopathic Parkinson's Disease

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Nasal and oral bacterial swabs and stool samples

• Sampling Method: Non-Probability Sample
• Study Population: Hospital patients in- and outpatient From the community
• Condition: Parkinson's Disease
• Intervention: Not Provided

Study 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 28, 2014): 150
• Original Estimated Enrollment (submitted: February 21, 2012): 200
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• over 50 years of age

Exclusion Criteria:

• Active smoking
• relevant gastrointestinal or ENT disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT01536769
• Other Study ID Numbers: 86/2011
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Filip Scheperjans, Helsinki University Central Hospital
• Original Responsible Party: Filip Scheperjans, Helsinki University Central Hospital, Neurology fellow
• Current Study Sponsor: Helsinki University Central Hospital
• Original Study Sponsor: Same as current

Collaborators

• Jorvi Hospital
• Hyvinkää Hospital
• Peijas Hospital
• University of Helsinki

Investigators

• Principal Investigator: Filip Scheperjans, MD, PhD; Helsinki University Central Hospital

• PRS Account: Helsinki University Central Hospital
• Verification Date: November 2016