Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital Européen Marseille

About this trial

Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated.

Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota.

The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria.

Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR)

patient not previously treated with biotherapy

Aged ≥ 18 years

Disqualifiers

Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling.

Association with another chronic pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • stool sampling

    Other intervention

    Participants will provide two stool samples: one collected the day of inclusion and a second, four months later after anti-TNF α or anti- IL-17 (interleukin-17) treatment initiation.

  • stool sampling

    Other intervention

    Participants will provide one stool sample at inclusion

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Patients with spondyloarthritis (Spa)Experimental treatment 1 intervention
Group B: Healthy subjectsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Variability in the qualitative and quantitative composition of intestinal microbiota in patients responding to biotherapy compared to the group of non-responding patients

Time frame
18 Months

Secondary outcomes

1

Differences on intestinal microbiota composition (qualitative and quantitative) of patients with Spa versus healthy controls.

Time frame
18 Months

Other outcomes

Sponsors and contacts

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