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

This study has been terminated.
(Lack of patients)
Information provided by (Responsible Party):
Nantes University Hospital Identifier:
First received: June 11, 2012
Last updated: November 30, 2016
Last verified: November 2016
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


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01618383

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

Responsible Party: Nantes University Hospital Identifier: NCT01618383     History of Changes
Other Study ID Numbers: RC11_0110
Study First Received: June 11, 2012
Last Updated: November 30, 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 processed this record on September 21, 2017