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NCT Number: NCT04959435

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

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.

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Key information

Conditions

Behçet Disease Behcet Syndrome Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases Microbiota Mouth Diseases Oral Microbiota Panuveitis Physiopathology Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Stomatognathic Diseases Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological samples collection

Other

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

Primary outcomes

  1. Oral microbiota

    Time frame: Day 0

    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.

Secondary outcomes

  1. Intestinal microbiota

    Time frame: Day 0

    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

  2. Short fatty acid

    Time frame: Day 0

    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

  3. Pro-inflammatory cytokines

    Time frame: Day 0

    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

  4. genital microbiota

    Time frame: Day 0

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: BEHCETBIOT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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