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Search / Trial NCT04853212

The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 16, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Spondyloarthritis Ruminococcus Gnavus Microbiota Dysbiosis

ClinConnect Summary

This clinical trial is studying the role of a specific bacterium called Ruminococcus gnavus in the development of a condition known as spondyloarthritis (SpA). Spondyloarthritis is a type of inflammatory arthritis that can cause pain and stiffness in the spine and joints. The researchers want to compare the gut bacteria of patients with spondyloarthritis to those who do not have this condition but are undergoing a digestive procedure for other reasons. By examining samples from the intestines and stools, they hope to understand how this bacterium might be linked to the onset of spondyloarthritis.

To participate in this study, you must be at least 18 years old and either have a diagnosis of spondyloarthritis or be a healthy control subject scheduled for a digestive endoscopy. Participants will need to provide informed consent and will be excluded if they have taken antibiotics recently, are pregnant or breastfeeding, or have certain severe health issues. If you join, you can expect to undergo testing that involves sampling your gut bacteria to help researchers learn more about the relationship between gut health and spondyloarthritis. Your participation could contribute valuable information that may help improve understanding and treatment of this condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with SPA:
  • Patients ⩾ 18 years;
  • Diagnosed as spondyloarthritis (SpA) according ASAS classification;
  • Affiliated to a social security scheme;
  • Have signed the written informed consent form.
  • Control subjects:
  • Subjects ⩾ 18 years;
  • Subjects free of SPA and planned for a digestive endoscopy for another indication such as to explore the risk of colorectal cancer in family member;
  • Affiliated to a social security scheme;
  • Have signed the written informed consent form.
  • Exclusion Criteria:
  • Subjects unable to understand the proposed study and/or sign a informed consent form;
  • Pregnant women or breast feeding women;
  • Subjects under guardianship or curatorship;
  • Have taken antibiotic 1 month prior to inclusion;
  • 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.

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Boulogne Billancourt, , France

Patients applied

0 patients applied

Trial Officials

Maxime BREBAN, MD, PhD

Principal Investigator

Service de Rhumatologie, Hôpital Ambroise Paré, APHP

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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