The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

Официальное название

The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis

Обзор

The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).

Подробное описание

As secondary objectives, the study aims:

* to research the abundance of bacterial strain of R. gnavus in mucosal sampling by biopsy; * to study the interaction between R. gnavus bacterium and mucus from histological sampling; * to correlate the expression of genes of intestinal mucus with the variations of identified microbiota of mucus biopsy; * to study the interaction between bacteria and intestinal epithelial cells during culture; * to demonstrate perturbations of the immune responses by dysbiosis.

Вмешательства

• Процедура Biopsy
  Biopsy during recto-coloscopy

Первичные конечные точки

• Isolation and characterization of R. gnavus [Срок оценки: At the end of study, up to 2 years]
• Bacteria analysis [Срок оценки: At the end of study, up to 2 years]

Вторичные конечные точки (5)

• Bacterial strain's abundance [Срок оценки: At the end of study, up to 2 years]
• Mucin-degradation of Ruminococcus gnavus [Срок оценки: At the end of study, up to 2 years]
• RNA sequencing analysis of biopsy [Срок оценки: At the end of study, up to 2 years]
• Interaction between bacteria and intestinal epithelial cells [Срок оценки: At the end of study, up to 2 years]
• Dysbiosis-induced immune perturbations [Срок оценки: At the end of study, up to 2 years]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Service de Rhumatologie, Hôpital Ambroise Paré, APHP — Boulogne-Billancourt

Публикации

• 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
• Crost EH, Tailford LE, Monestier M, Swarbreck D, Henrissat B, Crossman LC, Juge N. The mucin-degradation strategy of Ruminococcus gnavus: The importance of intramolecular trans-sialidases. Gut Microbes. 2016 Jul 3;7(4):302-312. doi: 10.1080/19490976.2016.1186334. Epub 2016 May 25. PMID 27223845

Идентификаторы

NCT: NCT04853212 · APHP210332 · 2020-A03244-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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