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

Parkinson's Disease Clinical Trial

— EnteroLarc  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01618383
• Other study ID #: RC11_0110
• Status: Terminated
• Phase: N/A
• First received: June 11, 2012
• Last updated: November 30, 2016
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• colonoscopy or rectosigmoidoscopy
Usual procedure

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry		3 months	No
Secondary	Analysis of intestinal permeability in biopsies using Ussing's chambers		3 months	No