Inserm U1071, M2iSH, USC-INRA 1382, Université Clermont Auvergne, Clermont-Ferrand, Auvergne-Rhône-Alpes, France
Médecine Interne, CHU Gabriel Montpied, CHU Clermont-Ferrand, Clermont-Ferrand, France.
BMJ Open. 2023 Aug 4;13(8):e073776. doi: 10.1136/bmjopen-2023-073776.
Aseptic abscess (AA) syndrome is a rare disease whose pathophysiology is unknown. It is often associated with inflammatory bowel disease and characterised by sterile inflammation with collections of neutrophils affecting several organs, especially the spleen. Microbiota are known to influence local and systemic immune responses, and both gut and oral microbiota perturbations have been reported in diseases associated with AA syndrome. However, interactions between these factors have never been studied in AA syndrome. The purpose of this translational case-control study (ABSCESSBIOT) is to investigate gut and/or oral microbiota in patients with AA syndrome compared with healthy controls. Moreover, microbiota associated metabolites quantification and Treg/Th17 balance characterisation will give a mechanistic insight on how microbiota may be involved in the pathophysiology of AA syndrome.
This French multicentre case-control study including 30 French centres (University hospital or regional hospital) aims to prospectively enrol 30 patients with AA syndrome with 30 matched controls and to analyse microbiota profiling (in stools and saliva), microbial metabolites quantification in stools and circulating CD4 T cell populations.
This study protocol was reviewed and approved by an independent French regional review board (n° 2017-A03499-44, Comité de Protection des Personnes Ile de France 1) on 10 October 2022, and declared to the competent French authority (Agence Nationale de Sécurité du Médicament et des produits de santé, France). Oral and written informed consent will be obtained from each included patient and the control participant. Study results will be reported to the scientific community at conferences and in peer-reviewed scientific journals.
Clinical Trials web-based platform (NCT05537909).
无菌脓肿（AA）综合征是一种罕见疾病，其发病机制尚不清楚。它通常与炎症性肠病有关，其特征是无菌性炎症伴有中性粒细胞聚集，影响多个器官，尤其是脾脏。微生物群被认为会影响局部和全身免疫反应，并且在与 AA 综合征相关的疾病中已经报道了肠道和口腔微生物群的紊乱。然而，这些因素之间的相互作用从未在 AA 综合征中进行过研究。本转化病例对照研究（ABSCESSBIOT）的目的是比较 AA 综合征患者与健康对照者的肠道和/或口腔微生物群。此外，对相关微生物群代谢物的定量和 Treg/Th17 平衡的特征描述将深入了解微生物群如何参与 AA 综合征的发病机制。
这项法国多中心病例对照研究包括 30 个法国中心（大学医院或区域医院），旨在前瞻性招募 30 例 AA 综合征患者和 30 名匹配的对照者，并分析微生物群谱（粪便和唾液）、粪便中微生物代谢物的定量和循环 CD4 T 细胞群体。
该研究方案于 2022 年 10 月 10 日由一个独立的法国地区审查委员会（编号 2017-A03499-44，巴黎大区保护委员会 1 号）进行了审查和批准，并向法国有关当局（法国药品和医疗产品安全局）进行了申报。将从每位纳入的患者和对照参与者处获得口头和书面知情同意。研究结果将在会议和同行评议的科学期刊上向科学界报告。
临床试验网络平台（NCT05537909）。
