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

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Rush

Status

Completed

Conditions

Multiple System Atrophy
Parkinson's Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01155492
07100403

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

43 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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