Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)

NCT04959435 | Completed

• 2 other identifiers: RBHP 2021 ANDRE2021-A01648-33
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Behçet Disease; Physiopathology; Microbiota; Oral Microbiota

Outcome Measures

Primary Outcomes (1)

• Oral microbiota

  Establish microbial profiles (quantitative and qualitative via analysis of bacterial DNA sequences encoding 16S rRNA) of dental plaque, pathological (on the aphta) and non-pathological oral mucosa and and salivary and compared them to control without Behçet's disease matched for sex, diet and socio-cultural level.

  Day 0

Secondary Outcomes (4)

• Intestinal microbiota

  Day 0

• Short fatty acid

  Day 0

• Pro-inflammatory cytokines

  Day 0

• genital microbiota

  Day 0

Study Arms (2)

Case

Behcet's disease patients

Other: biological samples collection

Controls

Controls that matched two to two at case according to sex,social status and diet.

Other: biological samples collection

Interventions

biological samples collection OTHER

samples of blood, faeces, saliva, dental plaque, oral mucosa, genital mucosa

Case; Controls

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient who have behçet's disease.

You may qualify if:

• Patients who meet the International criteria for the classification of Behçet's disease, revised in 2013)
• Patient who had developed the disease in the 5 years preceding the study.

You may not qualify if:

• Pregnant or breastfeeding women, or women who may be pregnant or breastfeeding.
• Subject placed under judicial protection.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Hopital La Pitié Salpetriere

Paris, 75000, France

Location

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Marc André

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: January 10, 2022
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)