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Increased Gut Permeability to Lipopolysaccharides (LPS) in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01155492
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Kathleen M. Shannon, Rush University Medical Center

Brief Summary:
The gut may be a portal of entry for agents that cause or contribute to the causes of Parkinson's disease (PD). The investigators are studying changes in the normal population of gut flora and in intestinal permeability and their associations with early PD.

Condition or disease
Parkinson's Disease Multiple System Atrophy

Detailed Description:
Clinical and pathological data suggest Parkinson's disease (PD) may result from an inflammatory process beginning in the intestinal wall that initiates alpha-synuclein aggregation, which then spreads from neuron to neuron, reaching the central nervous system. Bacteria living within the intestinal tract produce lipopolysaccharide endotoxin, a toxin known to induce parkinsonism in animal models. We hypothesize that exposure to LPS, either from excessive production or excessive absorption may be the cause of this inflammation. This study aims to: (1) describe differences in the population of gut bacteria in PD compared to control subjects; (2) assess leakiness of the gut wall by differential absorption of non-absorbable sugars; (3) measure plasma levels of endotoxin and inflammation; and (4) study characteristic PD pathology and evidence of inflammation in biopsy samples of the colon obtained by sigmoidoscopy.

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Increased Gut Permeability to Lipopolysaccharides (LPS) in Parkinson's Disease
Study Start Date : September 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Subjects with Parkinson's disease
Male and female subjects with clinically diagnosed Parkinson's disease, Stage I-IV.
Control subjects
Age- and gender-matched subjects who do not have Parkinson's disease
Multiple system atrophy.
Men and women with clinically diagnosed multiple system atrophy.

Primary Outcome Measures :
  1. Total urine sugar per 24 hours [ Time Frame: 24 hours ]
    Subjects consume a mixture of sugars (lactulose, sucrose), then collect urine for 24 hours. Sugar concentrations in the urine are assayed by gas chromatography.

  2. LH-PCR fingerprint analysis [ Time Frame: 24 hours ]
    Total genomic DNA will be extracted from colonic mucosa biopsy specimens and lumenal samples, and will be amplified by PCR using bacterial primers. PCR products will be separated and analyzed for amplicon length heterogeneity.

  3. Blood endotoxin and cytokine levels [ Time Frame: 24 hours ]
    Blood endotoxin and cytokine levels

  4. Histopathology and immunohistochemistry of colonic mucosa [ Time Frame: 24 hours ]
    A portion of the colonic tissue will be studied with histopathology and immunohistochemistry techniques for alpha-synuclein pathology, cytokines and inflammatory markers.

Biospecimen Retention:   Samples With DNA
Colonic mucosa biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Parkinson's disease Age- and gender-matched controls

Inclusion Criteria--Parkinson's disease:

  • Clinically diagnosed Parkinson's disease
  • Hoehn & Yahr stage 1-2.5
  • No symptomatic treatment of Parkinson's disease symptoms

Inclusion Criteria--Multiple System Atrophy

  • Clinically diagnosed Multiple System Atrophy.

Inclusion Criteria--Control subjects:

  • No diagnosis of Parkinson's disease and no signs of Parkinson's disease on screening neurological examination

Exclusion Criteria:

  • Secondary or atypical parkinsonism other than Multiple System Atrophy
  • Occupation or medical treatment known to influence intestinal flora
  • Organic gastrointestinal disease other than hiatal hernia or hemorrhoids; history of gastrointestinal surgery other than remote appendectomy or cholecystectomy.
  • Acute or chronic medical illness that would confound study results.
  • Coagulopathy or use of anticoagulant medications (including aspirin).
  • Chronic use of diuretics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01155492

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
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Principal Investigator: Kathleen M Shannon, M.D. Rush University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kathleen M. Shannon, Professor, Neurological Sciences, Rush University Medical Center Identifier: NCT01155492    
Other Study ID Numbers: 07100403
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013
Keywords provided by Kathleen M. Shannon, Rush University Medical Center:
colonic bacteria
intestinal permeability
Additional relevant MeSH terms:
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Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases