Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT) (NCT04959435) | Clinical Trial Compass
CompletedNot Applicable
Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)
France66 participantsStarted 2022-01-10
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is studying the oral microbiota in Behçet's disease, can you explain what researchers are trying to learn about the connection between mouth bacteria and how Behçet's disease develops or progresses?
2This trial has already been completed — is there any published data or preliminary findings from it that you've seen, and could those results affect how you might approach my care?
3Could my current treatments for Behçet's disease, like immunosuppressants or colchicine, affect my oral microbiota, and is that something worth monitoring as part of my overall management?
4Since this appears to be an observational study rather than a treatment trial, would participating in something like this — or a follow-up study — be a meaningful way for me to contribute to understanding Behçet's disease without changing my current treatment plan?
5Are there any practical steps, like improving oral hygiene or addressing gum disease, that might be worth considering given what researchers are exploring about the role of oral bacteria in Behçet's disease?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.