Analysis of the Enteric Nervous System Using Colonic Biopsies (ColoBioParker)
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ClinicalTrials.gov Identifier: NCT01353183 |
Recruitment Status
:
Completed
First Posted
: May 12, 2011
Last Update Posted
: September 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease Multiple System Atrophy Progressive Supranuclear Palsy | Procedure: colonoscopy or rectosigmoidoscopy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes? |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Colonic biopsies
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
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Procedure: colonoscopy or rectosigmoidoscopy
Usual procedure
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- Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry [ Time Frame: 3 months ]Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.
- Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis [ Time Frame: 3 months ]Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients
- Patients aged 50-80 year old, both genders
- Parkinson's disease patients
- Multiple system atrophy patients
- Progressive supranuclear palsy patients
- Controls: patient at risk of colic cancer for whom a colonoscopy is required
- Patients who signed the informed consent
Controls
- Patients aged 50 to 80 year-old for whom a rectosigmoidoscopy or a colonoscopy is required for colorectal screening
- Patients who signed the informed consent
- Health care beneficiary
Exclusion Criteria:
Patients
- Colonic disorder (except non-complicated diverticular disease)
- Other neurological disorder than parkinsonism
- Patients treated with either platelet antiaggregants, anticoagulants or with a known coagulation disorder
- Patients with a cognitive impairment that preclude them from understanding the informed consent
- Patients placed under legal guardianship
Controls
- Neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease or other dementia, amyotrophic lateral sclerosis...
- Functional bowel disorder such as irritable bowel syndrome
- Patients with a cognitive impairment that preclude them from understanding the informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT01353183
France | |
Nantes University Hospital | |
Nantes, France, 44093 |
Principal Investigator: | DERKINDEREN Pascal, Professor | Nantes University Hospital |
Responsible Party: | Nantes University Hospital |
ClinicalTrials.gov Identifier: | NCT01353183 History of Changes |
Other Study ID Numbers: |
10/4-U ID RCB 2010-A00632-37 ( Registry Identifier: 2010-A00632-37 ) |
First Posted: | May 12, 2011 Key Record Dates |
Last Update Posted: | September 19, 2013 |
Last Verified: | September 2013 |
Keywords provided by Nantes University Hospital:
biopsies, enteric nervous system, biomarker |
Additional relevant MeSH terms:
Parkinson Disease Atrophy Supranuclear Palsy, Progressive 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 |
Ophthalmoplegia Ocular Motility Disorders Cranial Nerve Diseases Tauopathies Paralysis Neurologic Manifestations Eye Diseases Signs and Symptoms Primary Dysautonomias Autonomic Nervous System Diseases Hypotension Vascular Diseases Cardiovascular Diseases |