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
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.
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:
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:
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 →Institut Pasteur is the lead sponsor of 98 studies on the registry; 40 are open to participants now.
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Parkinson patients and control subjects (spouse or matched controls)
Inclusion Criteria:
Patients (PD)
Controls
Exclusion Criteria (both PD patients and controls)
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
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
All
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
Epidemiological characteristics of patients PD
Demographic variables (locations of residence and types of housing), risk factors (activities, diet, history family).
Time frame: 4 years
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
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
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
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
Global cognitive performance - MoCA
The Montreal Cognitive Assessment (MoCA) will be used to assess global cognitive performance.
Time frame: 4 years
Executive functions
Frontal Assessment Battery (FAB) will be used to detect executive dysfunction.
Time frame: 4 years
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
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
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
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
Mood disorders - the MINI
The MINI, a clinician rating test, will also be used to assess depression severity.
Time frame: 4 years
Ran from Feb 2020 to primary completion in Apr 2024, 50 months.
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