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

Not Applicable

• Conditions: Spondyloarthritis
• Interventions: Other: stool sampling

• Registration Number: NCT04899154
• Lead Sponsor: Hôpital Européen Marseille

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-16
• Status Verified: 2021-05
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-24
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-28
• Primary Completion: 2022-07-15
• Study Completion: 2022-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with spondyloarthritis (Spa)	stool sampling	-
Healthy subjects	stool sampling	-

Primary Outcome Measures

Name	Time	Method
Variability in the qualitative and quantitative composition of intestinal microbiota in patients responding to biotherapy compared to the group of non-responding patients	18 Months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Européen Marseille; 🇫🇷 Marseille, France