Skip to content

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

MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04899154
Acronym
MEDIBIOTE 3
Enrollment
80
Registered
2021-05-24
Start date
2019-07-16
Completion date
2026-05-15
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthritis

Brief summary

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).

Interventions

OTHERstool sampling

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.

Sponsors

Hôpital Européen Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

For patient with spondyloarthritis: * 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 * Having given free and informed written consent * Being affiliated to the center national security system social For control Subject: * Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease. * Aged ≥ 18 years * Having given free and informed written consent * Being affiliated with or benefiting from a social security scheme.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Variability in the qualitative and quantitative composition of intestinal microbiota in patients responding to biotherapy compared to the group of non-responding patients18 Months

Secondary

MeasureTime frame
Differences on intestinal microbiota composition (qualitative and quantitative) of patients with Spa versus healthy controls.18 Months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026