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

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: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Diagnostic test: Nasal swab

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
nasal inflammatory microbiome	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

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 10, 2019
• Study Completion (Actual): September 10, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID 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