Behçet DiseaseBEHCETBIOTNCT04959435
Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)
An observational study of Behçet Disease and Physiopathology, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Behçet Disease, Physiopathology, Microbiota
- What is being tested?
- biological samples collection
- Type of treatment
- Pill or oral medicine
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Jan 2022to 21 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: Patient who have behçet's disease.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Hopital La Pitié Salpetriere
Paris, 75000
About this study
Official title: 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.
Read the 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.
- Conditions
- Behçet Disease, Physiopathology, Microbiota, Oral Microbiota
- Being tested
- biological samples collection
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samples collectionOther
samples of blood, faeces, saliva, dental plaque, oral mucosa, genital mucosa
| Study group | Role | What they receive |
|---|---|---|
| Case | Behcet's disease patients Receives: Other: biological samples collection | |
| Controls | Controls that matched two to two at case according to sex,social status and diet. Receives: Other: biological samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start10 Jan 2022
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc André, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959435
- Sponsor's protocol ID
- RBHP 2021 ANDRE
- Other IDs
- 2021-A01648-33
- Acronym
- BEHCETBIOT
- Status last verified
- Sep 2024
- First submitted
- 2 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are reserved for M2ISH laboratory team .
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Role of the Salivary Microbiota and Microbiota Associated to Mucosa in Behçet's Disease
- ClinicalTrials.gov ID
- NCT04959435
- Acronym / sponsor ID
- BEHCETBIOT / RBHP 2021 ANDRE
- Conditions
- Behçet Disease, Physiopathology, Microbiota, Oral Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: biological samples collectionBehcet's disease patients |
| Controls | – | Other: biological samples collectionControls that matched two to two at case according to sex,social status and diet. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patient who have behçet's disease.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samples collectionsamples of blood, faeces, saliva, dental plaque, oral mucosa, genital mucosa | Other | Case, Controls |
Primary outcome
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.
4 secondary outcomes
Intestinal microbiota
Time frame: Day 0
Short fatty acid
Time frame: Day 0
Pro-inflammatory cytokines
Time frame: Day 0
genital microbiota
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Data are reserved for M2ISH laboratory team .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc André principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet Disease and Physiopathology, run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral microbiota (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.