Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT04959435
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Understanding the Role of the Salivary Microbiota and Microbiota Associated to Mucosa in Behçet's Disease
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEHCETBIOT
Brief Summary:
Behçet's disease (BD) is a systemic vasculitis that affects, especially, young people.
Although its etiology remains unexplained, data suggest that the inflammatory response during BD results from a disruption of the homeostasis of innate and adaptive immune responses in genetically predisposed people. The microbiota could play a triggering role in BD, in particular the salivary and dental plaque microbiota. The aim of the Behçetbiot study is therefore to establish microbial profiles of dental plaque, pathological (on the mouth ulcer) and non-pathological mucous membrane, salivary and digestive and to compare them with control subjects not suffering from BD, related to the first degree, of the same socio-cultural level and to determine whether dysbiosis is correlated with a local and systemic pro-inflammatory response, by measuring salivary level of pro-inflammatory cytokines and blood level of CRP, fibrinogen, orosomucoïd and haptoglobin, and to compare them with controls.
Although its etiology remains unexplained, data suggest that the inflammatory response during BD results from a disruption of the homeostasis of innate and adaptive immune responses in genetically predisposed people. The microbiota could play a triggering role in BD, in particular the salivary and dental plaque microbiota. The aim of the Behçetbiot study is therefore to establish microbial profiles of dental plaque, pathological (on the mouth ulcer) and non-pathological mucous membrane, salivary and digestive and to compare them with control subjects not suffering from BD, related to the first degree, of the same socio-cultural level and to determine whether dysbiosis is correlated with a local and systemic pro-inflammatory response, by measuring salivary level of pro-inflammatory cytokines and blood level of CRP, fibrinogen, orosomucoïd and haptoglobin, and to compare them with controls.
Detailed Description:
All patients and their controls are sampled for stool, saliva, dantal plaque, oral mucosa, genital mucosa and blood during an annual follow-up visit or if they are hospitalised.
Plaque, oral mucosa, genital mucosa salivary and blood will be collected during an annual follow-up visit.
For stool samples, the collection material will be provided to the patient and they will be able to take the sample at home and bring it to the clinic, or send them via a carrier within 3 days.
All the samples related to the study will be taken in the internal medicine in Clermont-Ferrand (France) or Pitie Salpêtrière, department of internal medecine, Paris,France or ophthalmology departments in Clermont-Ferrand.
All sample will be stocked in biological center in Clermont-Ferrand before analyze.
Microbiota analyzes will be realise at M2iSH laboratoty, inflammatory cytokines will be analyze in Clermont-Ferrand immunology laboratory, and pro-inflammatory parameters will be analyse in biochimy laboratory in Clermont-Ferrand.
Plaque, oral mucosa, genital mucosa salivary and blood will be collected during an annual follow-up visit.
For stool samples, the collection material will be provided to the patient and they will be able to take the sample at home and bring it to the clinic, or send them via a carrier within 3 days.
All the samples related to the study will be taken in the internal medicine in Clermont-Ferrand (France) or Pitie Salpêtrière, department of internal medecine, Paris,France or ophthalmology departments in Clermont-Ferrand.
All sample will be stocked in biological center in Clermont-Ferrand before analyze.
Microbiota analyzes will be realise at M2iSH laboratoty, inflammatory cytokines will be analyze in Clermont-Ferrand immunology laboratory, and pro-inflammatory parameters will be analyse in biochimy laboratory in Clermont-Ferrand.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A01648-33 | OTHER | ANSM | View |