Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— MICROBIART  

Official title:

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04292067
• Other study ID #: APHP190991
• Secondary ID: 2019-A02632-55
• Status: Recruiting
• Start date: November 23, 2020
• Est. completion date: November 2024

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Maxime BREBAN, MD, PhD
• Phone: + 33 1 49 09 56 72
• Email: maxime.breban[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

Biological:
• Faecal sampling
Faecal sampling at baseline

Locations

Country	Name	City	State
France	Service de Rhumatologie, Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intestinal microbiota composition	Intestinal microbiota composition will be analysed	At the end of study, up to 4 years