Evaluation of a Biomarker Related to the GI Tract for the Diagnosis of Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Lipopolysaccharide Binding Protein as a Potential Biomarker of Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904240
• Other study ID #: 12102401-IRB01
• Status: Completed
• Phase: N/A
• First received: July 9, 2013
• Last updated: November 11, 2014
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 entire nervous system including the central, peripheral, and enteric nervous system. There is evidence that inflammation plays a major role in neurodegeneration in PD. In both the striatum and substantia nigra of PD patients activated microglia were found and proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF. An inflammation-driven animal model has emerged and has been widely accepted as a model of the disease based on lipopolysaccharide (LPS) induced neurotoxicity. LPS is an endotoxin found on the outer membrane of gram negative bacteria and humans are exposed to LPS through the intestinal tract. The intestinal tract and thus the enteric nervous system serve as a conduit to the central nervous system. It has been posited that the inflammatory process could gain access to the lower brainstem via the vagal nerve and then ascend through the basal mid- and forebrain until it reaches the cerebral cortex, producing various pre-motor and motor symptoms of PD along the way. LPS may be one of the inflammatory triggers involved in this process. Systemic exposure to bacterial endotoxin can be determined by measuring plasma LPS binding protein (LBP). A study of 9 patients with early PD (median Hoehn and Yahr stage 2) and age matched controls found that the PD subjects had a significantly lower mean level of plasma LBP compared to control subjects. The aim of the research plan is to establish LBP as a potential biomarker for PD across a spectrum of disease severity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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%

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

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	Lipopolysaccharide binding protein (LBP) level	measure serum and plasma LBP levels in PD patients and control subjects	one day	No