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

NCT01155492 | Completed

• 1 other identifier: 07100403
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Multiple System Atrophy

Keywords

lipopolysaccharides; etiology; inflammation; colonic bacteria; intestinal permeability

Outcome Measures

Primary Outcomes (4)

• Total urine sugar per 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.

  24 hours

• LH-PCR fingerprint analysis

  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.

  24 hours

• Blood endotoxin and cytokine levels

  Blood endotoxin and cytokine levels

  24 hours

• Histopathology and immunohistochemistry of colonic mucosa

  A portion of the colonic tissue will be studied with histopathology and immunohistochemistry techniques for alpha-synuclein pathology, cytokines and inflammatory markers.

  24 hours

Study Arms (3)

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.

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with Parkinson's disease Age- and gender-matched controls

You may qualify if:

• Clinically diagnosed Parkinson's disease
• Hoehn \& Yahr stage 1-2.5
• No symptomatic treatment of Parkinson's disease symptoms
• Clinically diagnosed Multiple System Atrophy.
• No diagnosis of Parkinson's disease and no signs of Parkinson's disease on screening neurological examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Forsyth CB, Shannon KM, Kordower JH, Voigt RM, Shaikh M, Jaglin JA, Estes JD, Dodiya HB, Keshavarzian A. Increased intestinal permeability correlates with sigmoid mucosa alpha-synuclein staining and endotoxin exposure markers in early Parkinson's disease. PLoS One. 2011;6(12):e28032. doi: 10.1371/journal.pone.0028032. Epub 2011 Dec 1.

  PMID: 22145021 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Colonic mucosa biopsies

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Inflammation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen M Shannon, M.D.

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Neurological Sciences

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: July 1, 2010
• Study Start: September 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

US (1)