Role of Gut Microbiota in the Pathophysiology of Aseptic Abscesses
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 25
- 主要终点
- Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
研究概览
简要总结
Aseptic abscess syndrome (AA) is a rare entity characterized by the occurrence of deep abscesses with no germ found. Antibiotic therapy is ineffective and they are sensitive to anti-inflammatory treatment with corticosteroids.
Gut microbiota is important for the development of the immune system. In Crohn's disease which is frequently associated with AA syndrome, dysbiosis is found but could also be involved in the immune response at a distance from the gut.
Stool, blood, saliva and urine samples will be taken from the patients included and their controls in the centers where they are followed. These biological samples will be transported to Clermont Ferrand using the same procedure (transporter and dry ice) where the following analyses will be performed: microbiota on stool and saliva, short chain fatty acids on stool and lymphocyte study on blood.
详细描述
- Included patients will be adult patients meeting the diagnostic criteria for aseptic abscess syndrome described by André et al.
- Controls will be adults without aseptic abscess syndrome living in the same environment as the patients, whether related to the patient or not.
Patients and controls must be able to provide informed consent and be affiliated with the French Social Security system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For cases: adult patients meeting the diagnostic criteria for aseptic abscess syndrome described by André et al:
- •Deep abscesses on radiological examination with neutrophilic features proven by pathological analysis of a surgical specimen or biopsy when performed
- •Negative blood cultures, negative serological tests for bacteria, including always Yersinia enterocolitica, and, during surgery or aspiration, sterile pus (with standard cultures, BAAR and fungal tests) Failure of antibiotic therapy, when prescribed, after at least 2 weeks for conventional antibiotic therapy and at least 3 months for anti-tuberculosis treatment
- •Rapid clinical improvement the day after the prescription of corticosteroids (at least 1/2 mg/kg prednisone or equivalent) followed by radiological improvement after 1 month of corticosteroids, sometimes in association with immunosuppressive treatments.
- •For controls: adult person living in the same environment as the case to which it is matched. Adult person living in the same household or near the patient.
- •For cases and controls:
- •Ability to provide informed consent.
- •Membership in the Social Security system.
排除标准
- •Pregnant women. Incapable patients Patients deprived of liberty Antibiotic therapy administered within 6 weeks prior to inclusion.
结局指标
主要结局
Gut microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls
时间窗: day 1
16S rRNA gene sequencing technique and illumina MiSeq platform to investigate the difference of gut microbiota diversity between patients with aseptic abscess syndrome and matched healthy controls.
Gut microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls
时间窗: day 1
16S rRNA gene sequencing technique and illumina MiSeq platform to investigate the difference of gut microbiota composition between patients with aseptic abscess syndrome and matched healthy controls.
次要结局
- Th17/Treg Lymphocytes phenotyping(day 1)
- Salivary microbiota profiling (diversity) of patients with aseptic abscess syndrome and matched healthy controls(day 1)
- Salivary microbiota profiling (composition) of patients with aseptic abscess syndrome and matched healthy controls(day 1)