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NCT Number: NCT04292067

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Boulogne-Billancourt, 92100, France

Location status: Recruiting

Location contact

Maxime BREBAN, MD, PhD

CONTACT

[email protected]

+33 1 49 09 56 72

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Faecal sampling

Biological

Faecal sampling at baseline

Blood sampling

Biological

Blood sampling at baseline

Primary outcomes

  1. Bacteria analysis

    Time frame: At the end of study, up to 4 years

    Quantitative analysis of repartition of bacteria in each group and the comparison between groups.

Secondary outcomes

  1. Intestinal microbiota composition

    Time frame: At the end of study, up to 4 years

    Intestinal microbiota composition will be analysed

Study contacts

Contact information is provided by the study sponsor or research team.

Maxime BREBAN, MD, PhD

CONTACT

[email protected]

+ 33 1 49 09 56 72

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: MICROBIART

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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