NCT04249245Completed
Role of Nasal Dysbiosis in Parkinson Disease
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 285 (actual)
- First submitted
- 20 Jan 2020
- Start date
- 14 Feb 2020
- Primary completion date
- 25 Apr 2024
- Lead sponsor
- Institut Pasteur
- Diseases
- Parkinson disease
- NCT number
- NCT04249245
What you commit to
- Study type: Observational
- Participants enrolled: 285
- From 14 Feb 2020 to the primary completion date, 25 Apr 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of a cold or acute pathology which could explain an original olfactory disorder other than Parkinson's disease
Other
- Use of nasal antiseptics within the last 3 months
- Refusal of or contraindication to nasal microbiota sampling
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pitié Salpêtrière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Universitaire Coordinator of this site? Confirm its status | Pointe-à-Pitre | Guadeloupe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.