Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation (EnteroLarc)
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
colonoscopy or rectosigmoidoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson's disease, gut, colon, biopsies, LRRK2
Eligibility Criteria
Inclusion Criteria:
- Patients aged 30-80, both genders
- Parkinson's disease patients
- Parkinson's disease patients with G2019S mutations
- Controls: patient at risk of colic cancer for whom a coloscopy is required
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Colonic biopsies
Arm Description
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
Outcomes
Primary Outcome Measures
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
Secondary Outcome Measures
Analysis of intestinal permeability in biopsies using Ussing's chambers
Full Information
NCT ID
NCT01618383
First Posted
June 11, 2012
Last Updated
November 30, 2016
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01618383
Brief Title
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
Acronym
EnteroLarc
Official Title
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of patients
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for the development of Lewy bodies disease, and a careful look at discrepancies between these two conditions may provide insight into the pathogenesis of PD. The early involvement of the enteric nervous system (ENS) during PD led to theories that an as yet unidentified external agent entering the ENS causes PD . If lesions of the ENS are found in patients who present with a genetic form of parkinsonism would go against this notion, and thus provide insight to the pathophysiology of the disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, gut, colon, biopsies, LRRK2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colonic biopsies
Arm Type
Other
Arm Description
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
Intervention Type
Other
Intervention Name(s)
colonoscopy or rectosigmoidoscopy
Intervention Description
Usual procedure
Primary Outcome Measure Information:
Title
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Analysis of intestinal permeability in biopsies using Ussing's chambers
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 30-80, both genders
Parkinson's disease patients
Parkinson's disease patients with G2019S mutations
Controls: patient at risk of colic cancer for whom a coloscopy is required
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiphaine ROUAUD, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
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