Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

Recruiting

• Conditions: Spondyloarthritis; Rheumatoid Arthritis
• Interventions: Biological: Faecal sampling

• Registration Number: NCT04292067
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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

Study Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Study Start: 2020-11-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with SPA	Faecal sampling	100 SPA patients
Healthy subjets	Faecal sampling	200 healthy subjets in control group
patients with RA	Faecal sampling	100 RA patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Intestinal microbiota composition	At the end of study, up to 4 years	Intestinal microbiota composition will be analysed

Trial Locations

Locations (1)

Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris; 🇫🇷 Boulogne-Billancourt, France