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Recruiting NCT04292067

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

— Observational Spondyloarthritis Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Faecal sampling, Blood sampling.
Who it may be relevant to
Registry conditions: Spondyloarthritis, Rheumatoid Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Biological Faecal sampling
    Faecal sampling at baseline
  • Biological Blood sampling
    Blood sampling at baseline

Primary outcome measures

  • Bacteria analysis [Time frame: At the end of study, up to 4 years]
Secondary outcome measures (1)
  • Intestinal microbiota composition [Time frame: At the end of study, up to 4 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris — Boulogne-Billancourt

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. PMID 28606969

Identifiers

NCT: NCT04292067 · APHP190991 · 2019-A02632-55

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗