Role of Nasal Dysbiosis in Parkinson Disease

NCT04249245 | Completed

• 1 other identifier: 2019-030
• Study Type: observational
• Target: 285
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Parkinson Disease

Keywords

Olfaction; Microbiota; Dysbiosis; Metagenomic analysis

Outcome Measures

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.

  4 years

Secondary Outcomes (12)

• Epidemiological characteristics of patients PD

  4 years

• Olfactory function

  4 years

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

  4 years

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

  4 years

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

  4 years

Study Arms (2)

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

Nasal Swab OTHER

All

Control Subjects; Parkinson Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson patients and control subjects (spouse or matched controls)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (2)

Pitie-Salpetriere Hospital

Paris, 75013, France

Location

Centre Hospitalier Universitaire

Pointe-à-Pitre, Guadeloupe

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal bacterial swab sample

MeSH Terms

Conditions

Parkinson Disease; Anosmia; Dysbiosis

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 30, 2020
• Study Start: February 14, 2020
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

GU (1); FR (1)