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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Nantes University Hospital
Information provided by (Responsible Party):
Nantes University Hospital Identifier:
First received: June 11, 2012
Last updated: December 22, 2015
Last verified: December 2015
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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of intestinal permeability in biopsies using Ussing's chambers [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: March 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01618383

Contact: Thiphaine ROUAUD, Doctor +33 240165199

University Hospital Recruiting
Nantes, France
Contact: Tiphaine ROUAUD, Doctor   
Contact: Pascal DERKINDEREN, Professor   
Principal Investigator: Tiphaine ROUAUD, Doctor         
Sub-Investigator: Pascal DERKINDEREN, Professor         
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: December 22, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders processed this record on May 26, 2016