The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients ⩾ 18 years;
Diagnosed as spondyloarthritis (SpA) according ASAS classification;
Affiliated to a social security scheme;
Have signed the written informed consent form.
Disqualifiers
Subjects unable to understand the proposed study and/or sign a informed consent form;
Pregnant women or breast feeding women;
Subjects under guardianship or curatorship;
Have taken antibiotic 1 month prior to inclusion;
Trial design
Design model
Parallel
Treatments tested in this trial
Biopsy
Procedure/SurgeryBiopsy during recto-coloscopy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: SPA patientActive comparator 1 intervention
Group B: Subject without SPASham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Isolation and characterization of R. gnavus
Isolation and characterization of R. gnavus bacterium from intestinal biopsy.
Time frame
At the end of study, up to 2 years2
Bacteria analysis
Analysis of repartition of R. gnavus bacterium in each group and the comparison between 2 groups.
Time frame
At the end of study, up to 2 yearsSecondary outcomes
1
Bacterial strain's abundance
Compare the abundance by RT-q-PCR of bacterial strain (R. gnavus) between mucus biopsy sampling and faecal sampling, collected from PCR patients or control subjects respectively.
Time frame
At the end of study, up to 2 years2
Mucin-degradation of Ruminococcus gnavus
Study the ability of the strain to grow on mucins of intestinal biopsy, colored after fixation to carnoy.
Time frame
At the end of study, up to 2 years3
RNA sequencing analysis of biopsy
RNA sequencing analysis of rectal biopsy between SPA patients and control subjects.
Time frame
At the end of study, up to 2 years4
Interaction between bacteria and intestinal epithelial cells
In order to study the interaction between bacteria and intestinal epithelial cells in culture (organoids). Study the induction of several target genes as peptides anti-microbians, mucin or chemokines by RT-q-PCR.
Time frame
At the end of study, up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov