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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01904240

Parkinson's Disease

COMPLETED

Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease

NCT03937284

Parkinson Disease

COMPLETED

Research Into the Expression of the csgA-gene and How it Changes in Patients With Parkinson's Disease

NCT07175922

Parkinsons Disease (PD)

RECRUITING

Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease

NCT03705520

Parkinson Disease

COMPLETED

Determining the Microbiota Composition of the Middle Meatus in Parkinson's

NCT03336697

Parkinson Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease Multiple System Atrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects with Parkinson's disease

Male and female subjects with clinically diagnosed Parkinson's disease, Stage I-IV.

No interventions assigned to this group

Control subjects

Age- and gender-matched subjects who do not have Parkinson's disease

No interventions assigned to this group

Multiple system atrophy.

Men and women with clinically diagnosed multiple system atrophy.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes