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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03336697
• Other study ID #: 16111609-IRB01
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: September 10, 2019

Study information

• Verified date: October 2019
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 10, 2019
• Est. primary completion date: March 10, 2019
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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