We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 13 for:    LRRK2

Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation (EnteroLarc)

This study has been terminated.
(Lack of patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618383
First Posted: June 13, 2012
Last Update Posted: December 1, 2016
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.
Information provided by (Responsible Party):
Nantes University Hospital
  Purpose
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.

Condition Intervention
Parkinson's Disease Other: colonoscopy or rectosigmoidoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Analysis of intestinal permeability in biopsies using Ussing's chambers [ Time Frame: 3 months ]

Enrollment: 19
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Colonic biopsies
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
Other: colonoscopy or rectosigmoidoscopy
Usual procedure

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01618383


Locations
France
University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Tiphaine ROUAUD, Doctor Nantes University Hospital
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01618383     History of Changes
Other Study ID Numbers: RC11_0110
First Submitted: June 11, 2012
First Posted: June 13, 2012
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Nantes University Hospital:
Parkinson's disease
gut
colon
biopsies
LRRK2

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases