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CompletedNCT04249245SMELLPARKUpdated Sep 19, 2024

Role of Nasal Dysbiosis in Parkinson Disease

An observational study in Parkinson Disease, sponsored by Institut Pasteur. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Institut Pasteur · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
285
Ages
18 Years and older
Sex
All
01

Study summary

Olfactory dysfunction is frequent in Parkinson Disease (PD) and may be present years before the motor symptoms appear. The early olfactory dysfunction could result from environmental factors acting through the nasal cavity such as microbial communities. In across-sectional bicentric study, groups of 160 PD patients and 160 controls will be compared for nasal microbiota composition according to their geographical origin. We will search an association between microbiota and the presence of an olfactory deficit, cognitive deficit and thymic disorder.

Read the detailed description

Olfactory dysfunction is frequent in Parkinson Disease (PD) and may be present years before the motor symptoms appear. The early olfactory dysfunction could result from environmental factors acting through the nasal cavity such as microbial communities. Local inflammation induced by a nasal bacterial dysbiosis (microbiota imbalance) could lead to early neuronal dysfunctions in the olfactory system propagating in all the brain, thus inducing motor, cognitive and emotional manifestations in PD, in keeping with the Braak's stage hypothesis. We propose a translational project aiming at investigating the potential influence of nasal dysbiosis in PD pathogenesis. First, we will analyze both olfaction and nasal microbiota in a large series of PD patients and test the link between olfactory deficits and nasal dysbiosis. Then, we will take advantage of studying two populations of subjects with a very different environmental exposure (in mainland France and French West Indies) to isolate the abnormalities of the nasal microbiota that could be specific for PD. The study will be performed in 160 patients and 160 healthy volunteers. Patients will be enrolled in two investigators sites of which different environmental exposure: 1) Guadeloupe Hospital, French West Indies and 2) Pitie-Salpetriere Hospital, Paris, France. The patient selection will be conducted in consultation with the physician and it will be proposed to the spouse to participate as controls. When the spouse cannot be included, a corresponding witness will be recruited.The study subjects will be enrolled after collecting their informed consent.

As soon as the study subjects are included, the following measurements will be done at once at the inclusion:

  • Neurological assessment: Idiopathic PD. Severity of the disease will be evaluated using the Hoehn and Yahr staging. Non-motor manifestations of the disease will be assessed using the Non-Motor Symptoms Scale (NMSS). Severity of REM behavior disorder will be evaluated using the Innsbruck REM sleep behaviour disorder inventory .
  • Olfactory function: Olfactory performance will be measured using (a) the Sniffin' Stick test battery (Burghardt, Wedel, Germany) following a standardized procedure and (b) a discrimination test of odorant mixtures developed by the Research Unit.
  • Global cognitive performance and executive functions: The Montreal Cognitive Assessment (MoCA) will be used to assess global cognitive performance. Frontal Assessment Battery (FAB) will be used to detect executive dysfunction.
  • Memory: The delayed paragraph recall index from the Wechsler Memory Scale IV-Revised will be employed as a valid, sensitive measure of verbal declarative memory and a surrogate marker of hippocampal function.
  • Mood disorders: Two self-questionnaires will be used: the Snaith-Hamilton pleasure scale to assess anhedonia severity, and the Quick inventory of depressive symptomatology-self-rated for depression intensity evaluation. Two clinician rating tests for depression severity will also be used: the Hamilton Depression Rating Scale 17 and the MINI.

Sampling of human microbiota will be performed at the end. Subjects will undergo nasal brushing from anterior nares after local epinephrine application with a sterile flocked swab inserted and gently rolled around the inside of both nostrils. Swabs (one per nostril) will be placed on ice immediately after collection and then frozen at -80°C before shipment to the Research Unit (Institut Pasteur) where analyses will be carried out:

  • Immunohistochemistry analysis: The levels of Neuroinflammation and aSyn proteins will be analyzed in the nasal tissue samples.
  • Microbiome analysis: Microbial composition will be determined by metagenomics (microbial whole genome sequencing).
02

Conditions studied

  • Parkinson Disease

Keywords

  • Olfaction
  • Microbiota
  • Dysbiosis
  • Metagenomic analysis
03

In context

Parkinson Disease

4,585 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 285 is above the median of 97 across 1,081 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Institut Pasteur is the lead sponsor of 98 studies on the registry; 40 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Parkinson patients and control subjects (spouse or matched controls)

Eligibility criteria

Inclusion Criteria:

Patients (PD)

  • Age > 18 years
  • Idiopathic PD
  • In Guadeloupe (N=80) : living for more than 15 years in Caribbean, including the 5 first years.
  • In Paris (N=80): living for more than 15 years in mainland France, including the 5 first years.

Controls

  • Age > 18 years
  • Spouse of enrolled PD patient or matched controls, with age difference between spouses \<5 years. When the spouse cannot be included, a matched control respecting the PD group's final sex ratio and with an age difference \<5 years relative to the concerned PD case will be enrolled.

Exclusion Criteria (both PD patients and controls)

  • Presence of a cold or acute pathology which could explain an original olfactory disorder other than Parkinson's disease
  • Use of nasal antiseptics within the last 3 months
  • Refusal of or contraindication to nasal microbiota sampling
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
285 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Parkinson Patients

    These patients are Hospitalized or consult in the participating hospitals of the Pointe à Pitre (Guadeloupe), or at the Pitié-Salpêtrière hospital (Paris). They were diagnosed Idiopathic PD (Parkinson Disease). The diagnosis is made according to the MDS criteria described in Postuma and al. 2015.

    Other: Nasal Swab

  • Control Subjects

    They are Spouse of Parkinson Patients group , with an age difference \<5 years compared to the patient concerned. If the Spouse can't be included, a corresponding control subject could be recruited in the consultation with an age difference \<5 years compared to the patient concerned, in respecting the final gender ratio of the PD group.

    Other: Nasal Swab

Interventions

  • OtherNasal Swab

    All

06

What researchers measure

Primary outcomes

  1. Bacterial composition of the nasal swab samples based on whole genome sequencing

    The amplicon sequence variants (ASV) will be constructed and comparison between groups will be performed.

    Time frame: 4 years

Secondary outcomes

  1. Epidemiological characteristics of patients PD

    Demographic variables (locations of residence and types of housing), risk factors (activities, diet, history family).

    Time frame: 4 years

  2. Olfactory function

    Olfactory performance will be measured using the Sniffin' Stick test battery (Burghardt, Wedel, Germany) following a standardized procedure and a discrimination test of odorant mixtures developed by the Research Unit

    Time frame: 4 years

  3. Neurological assessment: Idiopathic PD - Hoehn and Yahr staging.

    Severity of the disease will be evaluated using the Hoehn and Yahr staging.

    Time frame: 4 years

  4. Neurological assessment: Idiopathic PD - Non-Motor Symptoms Scale (NMSS)

    Severity of non-motor manifestations of the disease will be assessed using the Non-Motor Symptoms Scale (NMSS).

    Time frame: 4 years

  5. Neurological assessment: Idiopathic PD - the Innsbruck REM sleep behaviour disorder inventory

    Severity of REM behavior disorder will be evaluated using the Innsbruck REM sleep behaviour disorder inventory .

    Time frame: 4 years

  6. Global cognitive performance - MoCA

    The Montreal Cognitive Assessment (MoCA) will be used to assess global cognitive performance.

    Time frame: 4 years

  7. Executive functions

    Frontal Assessment Battery (FAB) will be used to detect executive dysfunction.

    Time frame: 4 years

  8. Memory Function

    The delayed paragraph recall index from the Wechsler Memory Scale IV-Revised will be employed as a valid, sensitive measure of verbal declarative memory and a surrogate marker of hippocampal function.

    Time frame: 4 years

  9. Mood disorders - the Snaith-Hamilton pleasure scale

    The Snaith-Hamilton pleasure scale (self-questionnaire) will be used to assess anhedonia severity,

    Time frame: 4 years

  10. Mood disorders - the Quick inventory of depressive symptomatology-self-rated

    The Quick inventory of depressive symptomatology-self-rated will be used for depression intensity evaluation.

    Time frame: 4 years

  11. Mood disorders - the Hamilton Depression Rating Scale 17

    The Hamilton Depression Rating Scale 17, a clinician rating test, will also be used to assess depression severity.

    Time frame: 4 years

  12. Mood disorders - the MINI

    The MINI, a clinician rating test, will also be used to assess depression severity.

    Time frame: 4 years

07

Study locations

2 sites
  • Pitie-Salpetriere Hospital
    Paris, 75013, France
  • Centre Hospitalier Universitaire
    Pointe-à-Pitre, Guadeloupe
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Apr 2024, 50 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2020
First posted
Jan 30, 2020
StartActual
Feb 14, 2020
Primary completionActual
Apr 25, 2024
CompletionActual
Apr 25, 2024
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04249245
Lead sponsor
Institut Pasteur
Responsible party
Sponsor
First posted
Jan 30, 2020
Start date
Feb 14, 2020
Primary completion
Apr 25, 2024
Completion
Apr 25, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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