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

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: NCT01618383
Recruitment Status : Terminated (Lack of patients)
First Posted : June 13, 2012
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: colonoscopy or rectosigmoidoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Colonic biopsies
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
Other: colonoscopy or rectosigmoidoscopy
Usual procedure

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01618383

University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Tiphaine ROUAUD, Doctor Nantes University Hospital

Responsible Party: Nantes University Hospital Identifier: NCT01618383     History of Changes
Other Study ID Numbers: RC11_0110
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Nantes University Hospital:
Parkinson's disease

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