Parkinson's DiseaseColoBioParkerNCT01353183
Analysis of the Enteric Nervous System Using Colonic Biopsies
A study testing colonoscopy or rectosigmoidoscopy in people with Parkinson's Disease and Multiple System Atrophy, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- What is being tested?
- colonoscopy or rectosigmoidoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?
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.
- Being tested
- colonoscopy or rectosigmoidoscopy
- Keywords
- biopsies, enteric nervous system, biomarker
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy or rectosigmoidoscopyProcedure or surgery
Usual procedure
| Study group | Role | What they receive |
|---|---|---|
| Colonic biopsies | Experimental | Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy Receives: Procedure: colonoscopy or rectosigmoidoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DERKINDEREN Pascal, Professor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353183
- Sponsor's protocol ID
- BRD/10/04-U
- Other IDs
- ID RCB 2010-A00632-37
- Acronym
- ColoBioParker
- Status last verified
- Sep 2013
- First submitted
- 31 Jan 2011
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?
- ClinicalTrials.gov ID
- NCT01353183
- Acronym / sponsor ID
- ColoBioParker / BRD/10/04-U
- Keywords
- biopsies, enteric nervous system, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic biopsies | Experimental | Procedure: colonoscopy or rectosigmoidoscopyColonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients
- Patients aged 50-80 year old, both genders
- Parkinson's disease patients
- Multiple system atrophy patients
- Progressive supranuclear palsy patients
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy or rectosigmoidoscopyUsual procedure | Procedure or surgery | Colonic biopsies |
Primary outcome
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
Time frame: 3 months
Colonic biopsies are obtained during the course of colonoscopy or rectosigmoidoscopy.
1 secondary outcome
Presence of alpha-synuclein aggregates in colonic biopsies using 2D electrophoresis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 23017648Devos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DERKINDEREN Pascal, Professor principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy or rectosigmoidoscopy in people with Parkinson's Disease and Multiple System Atrophy, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01353183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.