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Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04292067
Acronym
MICROBIART
Enrollment
400
Registered
2020-03-02
Start date
2020-11-23
Completion date
2026-11-30
Last updated
2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthritis, Rheumatoid Arthritis

Keywords

Spondyloarthritis, Rheumatoid Arthritis, Microbiota

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.

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.

Interventions

BIOLOGICALFaecal sampling

Faecal sampling at baseline

BIOLOGICALBlood sampling

Blood sampling at baseline

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Bacteria analysisAt the end of study, up to 4 yearsQuantitative analysis of repartition of bacteria in each group and the comparison between groups.

Secondary

MeasureTime frameDescription
Intestinal microbiota compositionAt the end of study, up to 4 yearsIntestinal microbiota composition will be analysed

Countries

France

Contacts

Primary ContactMaxime BREBAN, MD, PhD
maxime.breban@aphp.fr+ 33 1 49 09 56 72

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026