Status:
COMPLETED
Determining the Microbiota Composition of the Middle Meatus in Parkinson's
Lead Sponsor:
Rush University Medical Center
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-75 years
Brief 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 ...
Eligibility Criteria
Inclusion
- \- 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
- 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:
- Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X\> normal);
- Kidney disease (creatinine\>2.0 mg/dL);
- Uncontrolled psychiatric illness;
- Clinically important lung disease or heart failure;
- HIV disease;
- 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;
- Transplant recipients;
- Diabetes;
- 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
Key Trial Info
Start Date :
July 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 10 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03336697
Start Date
July 1 2017
End Date
September 10 2019
Last Update
October 4 2019
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612