Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient ⩾ 18 years;
Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;
Affiliated to a social security scheme;
Have signed the written informed consent form.
Disqualifiers
Patients unable to understand the proposed study and/or sign a informed consent form;
Pregnant women or breast feeding women;
Patient ⩾ 18 years;
Patients under guardianship or curatorship;
Trial population
* Adult patient diagnosed spondyloarthritis or rheumatoid polyarthritis; * Healthy adult subjects free of chronic pathology.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Faecal sampling
Biological/VaccineFaecal sampling at baseline
Blood sampling
Biological/VaccineBlood sampling at baseline
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: patients with SPA2 interventions
Group B: Healthy subjets2 interventions
Group C: patients with RA2 interventions
Trial outcomes
Primary outcomes
1
Bacteria analysis
Quantitative analysis of repartition of bacteria in each group and the comparison between groups.
Time frame
At the end of study, up to 4 yearsSecondary outcomes
1
Intestinal microbiota composition
Intestinal microbiota composition will be analysed
Time frame
At the end of study, up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov