Status:
COMPLETED
Evaluation of a Biomarker Related to the GI Tract for the Diagnosis of Parkinson's Disease
Lead Sponsor:
Rush University Medical Center
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-90 years
Brief Summary
The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed throughout the e...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Parkinson's disease subjects:
- Patients with a clinical diagnosis of Parkinson's disease by United Kingdom Parkinson Disease Society Brain Bank criteria will be recruited.
- Hoehn and Yahr stage 1-5
- Parkinson's disease symptomatic treatment will be allowed.
- Exclusion Criteria for Parkinson's disease subjects:
- Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents)
- Known diagnosis of inflammatory bowel disease.
- Symptomatic functional GI disease that significantly impairs intestinal mobility such as scleroderma or use of GI motility drugs.
- Acute illness requiring immediate hospitalization.
- Presence of short bowel syndrome or severe malnutrition with ideal body weight \< or = 90%
- Inclusion Criteria for control subjects:
- No evidence of GI symptoms other than minor hematochezia attributable to hemorrhoids.
- No evidence of symptoms of Parkinson's disease.
- Matching in age and gender to the Parkinson's disease patients.
- Exclusion Criteria for control subjects:
- Presence of Parkinson's disease or its symptoms.
- Treatment with medications that may induce parkinsonism (metoclopramide, typical, or atypical antipsychotic agents)
- Known diagnosis of inflammatory bowel disease.
- Symptomatic functional GI disease that significantly impairs intestinal mobility such as scleroderma or use of GI motility drugs.
- Acute illness requiring immediate hospitalization.
- Presence of short bowel syndrome or severe malnutrition with ideal body weight \< or = 90%
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01904240
Start Date
July 1 2013
End Date
June 1 2014
Last Update
November 13 2014
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612