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

Understanding the Role of the Salivary Microbiota and Microbiota Associated to Mucosa in Behçet's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Behçet Disease; Microbiota; Physiopathology; Oral Microbiota
• Intervention / Treatment: Other: biological samples collection

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Marc Andre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who have behçet's disease.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Pregnant or breastfeeding women, or women who may be pregnant or breastfeeding.
• Subject placed under judicial protection.
• Patient had received antibiotic or probiotic or symbiotic therapy in the 6 weeks preceding inclusion

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Behcet's disease patients	Other: biological samples collection; samples of blood, faeces, saliva, dental plaque, oral mucosa, genital mucosa
Controls; Controls that matched two to two at case according to sex,social status and diet.	Other: biological samples collection; samples of blood, faeces, saliva, dental plaque, oral mucosa, genital mucosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal microbiota	Establish microbial profiles (quantitative and qualitative via analysis of DNA sequences encoding 16S rRNA) of the intestinal microbiota by studying feces and comparing them to controls without Behçet's disease, of the same sex, diet and socio-cultural level	Day 0
Short fatty acid	Determination of short-chain fatty acids (HPLC technique) in the stools of Behçet patients and compare them to control patients without Behçet's disease, of the same sex, diet and socio-cultural level	Day 0
Pro-inflammatory cytokines	Determination of blood and saliva levels of IL-1beta, IL-6, IL-17, IL21, IL-23, Il-10, IFN gamma and TNF alpha (ELISA technique or multiplexed assay) and compare them to patients without Behçet disease, of the same sex, diet and socio-cultural level. socio-cultural level	Day 0
genital microbiota	Establish microbial profiles (quantitative and qualitative via analysis of DNA sequences encoding 16S rRNA) of the intestinal microbiota by studying feces and comparing them to controls without Behçet's disease, of the same sex, diet and socio-cultural level	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Marc André, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome
• Other Study ID Numbers: RBHP 2021 ANDRE; 2021-A01648-33 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data are reserved for M2ISH laboratory team .

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No