Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01618383
First received: June 11, 2012
Last updated: November 30, 2016
Last verified: November 2016

June 11, 2012
November 30, 2016
March 2012
October 2013   (final data collection date for primary outcome measure)
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01618383 on ClinicalTrials.gov Archive Site
Analysis of intestinal permeability in biopsies using Ussing's chambers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Parkinson's Disease
Other: colonoscopy or rectosigmoidoscopy
Usual procedure
Colonic biopsies
Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy
Intervention: Other: colonoscopy or rectosigmoidoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01618383
RC11_0110
Yes
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Tiphaine ROUAUD, Doctor Nantes University Hospital
Nantes University Hospital
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP