Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis (MICROBIART)

The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Spondyloarthritis
• Intervention / Treatment: Biological: Faecal sampling; Biological: Blood sampling

Detailed Description

As secondary objectives, the study aims to analyse the relation between different clinical parameters such as age, gender, duration of the disease, or the nature of ongoing treatment, and the the composition of intestinal microbiota, and identify dysbiosis of bacteria, which will be specific functional signatures of intestinal microbiota in SPA and/or RA. Analyse the relation between metabolome of faecale and plasma and the composition of intestinal microbiota.

This study will be performed in the rheumatology department in Ambroise Paré hospital of APHP group in France.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Maxime BREBAN, MD, PhD; Phone Number: + 33 1 49 09 56 72; Email: maxime.breban@aphp.fr

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Recruiting
    • Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris
    • Contact: Maxime BREBAN, MD, PhD; Phone Number: +33 1 49 09 56 72; Email: maxime.breban@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• Adult patient diagnosed spondyloarthritis or rheumatoid polyarthritis;
• Healthy adult subjects free of chronic pathology.

Description

Inclusion Criteria:

Patients:

• Patient ⩾ 18 years;
• Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR/EULAR;
• Affiliated to a social security scheme;
• Have signed the written informed consent form.

Healthy control subjects:

• Adult women and men;
• Subjet free of chronic pathology;
• Affiliated to a social security scheme;
• Have signed the written informed consent form.

Exclusion Criteria:

Patients:

• Patients unable to understand the proposed study and/or sign a informed consent form;
• Pregnant women or breast feeding women;
• Patient ⩾ 18 years;
• Patients under guardianship or curatorship;
• Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;
• Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
• Foreign patients under french AME scheme;
• Patients had have participated in the prior study Microbiart.

Healthy control subjects:

• Subjects unable to understand the proposed study and/or sign a informed consent form;
• Pregnant women or breast feeding women;
• Subjects < 18 years;
• Subjects under guardianship or curatorship;
• Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
• Refusal of subjects to participate to the study;
• Foreign patients under french AME scheme;
• Subjects had have participated in the prior study Microbiart.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with SPA; 100 SPA patients	Biological: Faecal sampling; Faecal sampling at baseline; Biological: Blood sampling; Blood sampling at baseline
Healthy subjets; 200 healthy subjets in control group	Biological: Faecal sampling; Faecal sampling at baseline; Biological: Blood sampling; Blood sampling at baseline
patients with RA; 100 RA patients	Biological: Faecal sampling; Faecal sampling at baseline; Biological: Blood sampling; Blood sampling at baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteria analysis	Quantitative analysis of repartition of bacteria in each group and the comparison between groups.	At the end of study, up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal microbiota composition	Intestinal microbiota composition will be analysed	At the end of study, up to 4 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Maxime BREBAN, MD, PhD, Service de Rhumatologie, Hôpital Ambroise Paré, APHP

Publications and helpful links

General Publications

• Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Microbiota; Rheumatoid Arthritis; Spondyloarthritis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Arthritis; Spondylitis; Spondylarthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: APHP190991; 2019-A02632-55 (Registry Identifier: IDRCB)

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