Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

NCT04292067 | Recruiting

• 2 other identifiers: APHP1909912019-A02632-55
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spondyloarthritis; Rheumatoid Arthritis

Keywords

Spondyloarthritis; Rheumatoid Arthritis; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intestinal microbiota composition

  At the end of study, up to 4 years

Study Arms (3)

patients with SPA

100 SPA patients

Biological: Faecal sampling; Biological: Blood sampling

Healthy subjets

200 healthy subjets in control group

Biological: Faecal sampling; Biological: Blood sampling

patients with RA

100 RA patients

Biological: Faecal sampling; Biological: Blood sampling

Interventions

Faecal sampling BIOLOGICAL

Faecal sampling at baseline

Healthy subjets; patients with RA; patients with SPA

Blood sampling BIOLOGICAL

Blood sampling at baseline

Healthy subjets; patients with RA; patients with SPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris

Boulogne-Billancourt, 92100, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 28606969 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal sampling at baseline for each subject

MeSH Terms

Conditions

Spondylarthritis; Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maxime BREBAN, MD, PhD

  Service de Rhumatologie, Hôpital Ambroise Paré, APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime BREBAN, MD, PhD

CONTACT

+ 33 1 49 09 56 72; maxime.breban@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: November 23, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)