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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Spondyloarthritis
• Intervention / Treatment: Other: stool sampling; Other: stool sampling

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Recruiting
    • Hopital européen Marseille
    • Contact: Myriam BENNANI; Phone Number: 04 13 42 83 51; Email: m.bennani@hopital-europeen.fr
    • Principal Investigator: Caroline CHARPIN, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with spondyloarthritis (Spa)	Other: stool 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.; Other: stool sampling; Participants will provide one stool sample at inclusion
Experimental: Healthy subjects	Other: stool 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.; Other: stool sampling; Participants will provide one stool sample at inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 2018-A03050-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No