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CompletedNCT01353183ColoBioParkerUpdated Sep 14, 2026

Analysis of the Enteric Nervous System Using Colonic Biopsies

An interventional study of colonoscopy or rectosigmoidoscopy in Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
All
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Study summary

The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.

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Conditions studied

  • Parkinson's Disease
  • Multiple System Atrophy
  • Progressive Supranuclear Palsy

Keywords

  • biopsies, enteric nervous system, biomarker
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients

  • Patients aged 50-80 year old, both genders
  • Parkinson's disease patients
  • Multiple system atrophy patients
  • Progressive supranuclear palsy patients
  • Controls: patient at risk of colic cancer for whom a colonoscopy is required
  • Patients who signed the informed consent

Controls

  • Patients aged 50 to 80 year-old for whom a rectosigmoidoscopy or a colonoscopy is required for colorectal screening
  • Patients who signed the informed consent
  • Health care beneficiary

Exclusion criteria

Exclusion Criteria:

Patients

  • Colonic disorder (except non-complicated diverticular disease)
  • Other neurological disorder than parkinsonism
  • Patients treated with either platelet antiaggregants, anticoagulants or with a known coagulation disorder
  • Patients with a cognitive impairment that preclude them from understanding the informed consent
  • Patients placed under legal guardianship

Controls

  • Neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease or other dementia, amyotrophic lateral sclerosis...
  • Functional bowel disorder such as irritable bowel syndrome
  • Patients with a cognitive impairment that preclude them from understanding the informed consent
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Colonic biopsies

    Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy

    Procedure: colonoscopy or rectosigmoidoscopy

Interventions

  • Procedurecolonoscopy or rectosigmoidoscopy

    Usual procedure

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What researchers measure

Primary outcomes

  1. Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry

    Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

    Time frame: 3 months

Secondary outcomes

  1. Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis

    Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.

    Time frame: 3 months

07

Study locations

1 site
  • Nantes University Hospital
    Nantes, 44093, France
08

References and documents

Publications

  • Devos D, Lebouvier T, Lardeux B, Biraud M, Rouaud T, Pouclet H, Coron E, Bruley des Varannes S, Naveilhan P, Nguyen JM, Neunlist M, Derkinderen P. Colonic inflammation in Parkinson's disease. Neurobiol Dis. 2013 Feb;50:42-8. doi: 10.1016/j.nbd.2012.09.007. Epub 2012 Sep 24. PubMed 23017648 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01353183
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
May 12, 2011
Start date
Nov 2010
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Sep 14, 2026

Study contacts

DERKINDEREN Pascal, Professor
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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