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



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:45 - 75
Updated:7/25/2018
Start Date:July 1, 2017
End Date:July 1, 2019
Contact:Gian D Pal, MD, MS
Email:gian_d_pal@rush.edu
Phone:3125632900

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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.


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
We found this trial at
1
site
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Gian D Pal, MD, MS
Phone: 312-563-2900
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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