Parkinson's DiseaseEnteroLarcNCT01618383
Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
A study testing colonoscopy or rectosigmoidoscopy in people with Parkinson's Disease, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- colonoscopy or rectosigmoidoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Oct 2013
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parkinson's Disease
- Being tested
- colonoscopy or rectosigmoidoscopy
- Keywords
- Parkinson's disease, gut, colon, biopsies, LRRK2
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy or rectosigmoidoscopyOther
Usual procedure
| Study group | Role | What they receive |
|---|---|---|
| Colonic biopsies | Other | Colonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy Receives: Other: 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
Measured: 3 months
Secondary outcomes (1)
Analysis of intestinal permeability in biopsies using Ussing's chambers
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 posted13 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine ROUAUD, Doctor, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618383
- Sponsor's protocol ID
- RC11_0110
- Acronym
- EnteroLarc
- Status last verified
- Nov 2016
- First submitted
- 11 Jun 2012
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation
- ClinicalTrials.gov ID
- NCT01618383
- Acronym / sponsor ID
- EnteroLarc / RC11_0110
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, gut, colon, biopsies, LRRK2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jun 2012 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic biopsies | Other | Other: colonoscopy or rectosigmoidoscopyColonic biopsies obtained during the course of colonoscopy or rectosigmoidoscopy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
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 | Other | Colonic biopsies |
Primary outcome
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
Time frame: 3 months
1 secondary outcome
Analysis of intestinal permeability in biopsies using Ussing's chambers
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
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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.
Tiphaine ROUAUD, Doctor 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, 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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 1 Dec 2016. 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 was stopped early (reason given: Lack of patients). Results are not available in the source record.
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?
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 1 Dec 2016.