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Enteric Nervous System in Parkinson's Disease (ENTEROPARK)

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: NCT00491062
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : November 16, 2010
Information provided by:
Nantes University Hospital

Brief Summary:
The "core" of the neuronal lesions in Parkinson's disease (PD) is the progressive degeneration of dopamine neurons in the substantia nigra. A significant loss of dopamine neurons and the presence of Lewy bodies (a pathological hallmark in PD) in enteric neurons have also been reported in that disease. These lesions may explain the frequent gastro-intestinal dysfunction observed in PD patients. Alterations of other neuronal populations within the enteric nervous system (ENS) as well as the mechanisms responsible for these lesions (type of cell death, alteration of neuromediators gene expression) remain to be identified. The aim of the study is to demonstrate that alterations of the human ENS in PD can be evidenced by bowel biopsies and to determine whether they are correlated to the severity of motor disability and to gastrointestinal dysfunction.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: Biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Official Title: Analysis of Dopamine Neuronal Cell Loss Within the Enteric Nervous System in Parkinson's Disease
Study Start Date : June 2007
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Control Procedure: Biopsies
Experimental: Parkinson stade 1 Procedure: Biopsies
Experimental: Parkinson stade2 Procedure: Biopsies
Experimental: Parkinson stade 3 Procedure: Biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Parkinson's disease patients at 3 different stages:

    • Early PD (before L-DOPA-induced complication);
    • Patients with L-DOPA-induced complication;
    • Patients with balance impairment or cognitive decline.
  • Controls: patient at risk of colic cancer for whom a coloscopy is required.

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): NCT00491062

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CHU Nantes Gastro-enterologic and Neurologic Service
Nantes, Loire-Atlantique, France, 44000
Sponsors and Collaborators
Nantes University Hospital
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Study Director: DAMIER Philippe CHU Nantes

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00491062    
Other Study ID Numbers: 06-5-I
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010
Keywords provided by Nantes University Hospital:
Parkinson's disease
enteric nervous system
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases