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

Spondyloarthritis Clinical Trial

— MEDIBIOTE 3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899154
• Other study ID #: 2018-A03050-55
• Status: Recruiting
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: December 15, 2022

Study information

• Verified date: May 2021
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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-TNFa 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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Européen Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Differences on intestinal microbiota composition (qualitative and quantitative) of patients with Spa versus healthy controls.		18 Months