Determining the Microbiota Composition of the Middle Meatus in Parkinson's

October 3, 2019 updated by: Gian Pal, Rush University Medical Center

Determining the Microbiota Composition of the Middle Meatus in Parkinson's Disease

The exact cause of PD remains unknown, but current theories suggest that it results from a combination of hereditary or genetic factors (i.e. family traits ) and exposure to unknown substances in the environment. The purpose of this study is to investigate whether toxins produced by bacteria that live within the nasal canal (nose) and the intestines of people with PD might have a role in causing the disease. The investigators in this study would like to look at the types of bacteria that live in the nasal canals and intestines of PD subjects and compare them with those of subjects who do not have PD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Early to moderate stage Parkinson's disease subjects.

Description

Inclusion Criteria:

- 1. Patients with a clinical diagnosis of Parkinson's disease by United Kingdom Parkinson Disease Society Brain Bank criteria will be recruited.

2. Hoehn & Yahr stage 1-3 3. Parkinson's disease symptomatic treatment will be allowed. 4. Subjects with deep brain stimulation are allowed.

Exclusion Criteria:

  • 1. Occupation expected to change intestinal flora pattern (e.g. sanitation worker) 2. Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents) 3. Treatment within 12 weeks with systemic antibiotics 4. Known diagnosis of inflammatory bowel disease 5. Symptomatic organic GI disease other than hemorrhoids and hiatal hernia or abdominal surgeries for symptomatic GI disease such as bowel resection, diverticular surgery, colostomy, etc (subjects with a history of an appendectomy or cholesytectomy for benign disease more than 5 years prior to presentation are allowed).

    6. Symptomatic functional GI disease that significantly impairs intestinal motility such as scleroderma or use of GI motility drugs 7. Acute illness requiring immediate hospitalization 8. Pre-existent organ failure or comorbidities as these may change GI flora:

    1. Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X> normal);
    2. Kidney disease (creatinine>2.0 mg/dL);
    3. Uncontrolled psychiatric illness;
    4. Clinically important lung disease or heart failure;
    5. HIV disease;
    6. Alcoholism, unreliable drinking history; or consumption of alcohol more than 3 times a week or binge drinking or drinking more than or equal to 3 drinks per occasion;
    7. Transplant recipients;
    8. Diabetes;
    9. Clinically significant dehydration or clinically detectable ascites or peripheral edema or cardiac failure 9. Presence of short bowel syndrome or severe malnutrition with ideal body weight < or = 90% or 10. Estimated survival <1 year and Karnofsky performance status <50%; 11. Use of immunosuppressive medications within 3 months of enrollment 12. Chronic use of diuretics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Parkinson's disease subjects
Patients with untreated or treated Parkinson's disease ages 45-75.
Diagnostic test: Nasal swab
a nasal swab will be performed by a trained physician by gently passing of a cotton swab in the nasal passage to get samples from middle meatus. This will be performed under guide of nasal anterior endoscopy to visualize the location of sampling. The cotton swab heads will be placed in sterile tubes and frozen at -80°C until DNA extraction.
Healthy control subjects
Healthy control subjects ages 45-75.
Diagnostic test: Nasal swab
a nasal swab will be performed by a trained physician by gently passing of a cotton swab in the nasal passage to get samples from middle meatus. This will be performed under guide of nasal anterior endoscopy to visualize the location of sampling. The cotton swab heads will be placed in sterile tubes and frozen at -80°C until DNA extraction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
nasal inflammatory microbiome
Time Frame: 1 year
For microbiome analysis, in silico community functional predictions will be performed using PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) and significant differences in Kyoto Encyclopedia of Genes and Genomes (KEGG) ortholog (KO) abundances between groups will be identified. "proinflammatory" and "anti-inflammatory" bacteria taxa will be classified and differences in inflammatory metabolite abundance will be compared.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16111609-IRB01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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