Host-microbiota Interactions in Auto-inflammatory Diseases (HO-MICRO-MAI)
研究概览
地位
条件
详细说明
Patients will receive oral and written information about the research during a routine consultation.
A 10mL urine tube will be collected for research. A stool collection kit including a self-questionnaire to be filled out on the day of the stool collection will be given to all included patients to be collected on site or at home within three months after inclusion and to be returned to the laboratory by mail using a pre-stamped envelope provided at the time of inclusion and a self-questionnaire to be filled out on the day of the stool collection Blood and urine samples will be brought by an accredited carrier to the laboratory "Microbiota, Intestine and Inflammation"; UMRS-938 Sorbonne University, Hôpital Saint-Antoine where they will be analyzed. Stool samples will be sent by mail for stool samples.
If blood sampling is planned as part of routine care, 3 additional tubes (15mL, one dry tube of 5mL, 2 EDTA tubes of 5mL each) of peripheral blood will be collected.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Sophie GEOGIN-LAVIALLE, MD PhD
- 电话号码:+33 01 56 01 70 82
- 邮箱:sophie.georgin-lavialle@aphp.fr
研究联系人备份
- 姓名:Inès ELHANI, MD
- 电话号码:+33 01 56 01 70 82
- 邮箱:ines.elhani@aphp.fr
学习地点
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-
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Paris、法国、75020
- 招聘中
- Internal medicine, Tenon Hospital (APHP)
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接触:
- Inès ELHANI, MD
- 电话号码:+33 01 56 01 70 82
- 邮箱:ines.elhani@aphp.fr
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接触:
- Sophie GEORGIN-LAVIALLE, MD, PhD
- 电话号码:+33 01 56 01 70 82
- 邮箱:sophie.georgin-lavialle@aphp.fr
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with autoinflammatory diseases aged >12 years and followed in the CEREMAIA internal medicine department present for consultation or day hospital for a routine care visit.
- FMF defined by the Eurofever/PRINTO criteria
- or CAPS définie by the Eurofever/PRINTO criteria
- or MKD defined by the Eurofever/PRINTO criteria
- or - DADA2 defined by the presence of two mutations in the ADA2 gene with pathogenicity of at least ≥ 3
- or - HA20 defined by the presence of one TNFAIP3 mutation with pathogenicity of at least ≥ 3
- or - JAAD defined by the presence of one JAK1 mutation with pathogenicity of at least ≥ 3
- or Juvenile polyarthritis defined by the presence of one LACC1 mutation with pathogenicity of at least ≥ 3
or - Unclassified AMI defined by:
- Fever +/- systemic symptoms Recurrent
- Biological inflammation (CRP>20mg/l) in crisis or permanent
- Absence of pathogenic mutation highlighted by current next-generation sequencing techniques in known autoinflammatory disease genes
- Collection of non-opposition to participation in research and specific consent for the biological collection of the patient or their legal representative in the case of a minor patient
- Lack of legal protection
- Patients benefiting from a social security scheme
Exclusion Criteria:
- Antibiotic therapy within 3 months prior to inclusion. If antibiotic therapy was initiated between inclusion and stool collection (data collected on the self-administered questionnaire accompanying the stool collection), the analysis data performed prior to antibiotic therapy will be retained, and the stool will not be analyzed.
- Current infection on the day of inclusion
- No social security
- Refusal to participate
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
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Patients with autoinflammatory diseases
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Stool and blood Gut-derived metabolites in patients with AID
大体时间:3 months
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Quantification of gut-derived metabolites in stools using mass spectrometry
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3 months
|
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Stool and blood Gut-derived metabolites in patients with AID
大体时间:3 months
|
Qualitative evaluation of gut-derived metabolites in stools
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3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Role of AhR on activation of inflammatory pathways
大体时间:during the inclusion visit, baseline, day 1
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Quantification of pro-inflammatory cytokines in presence of AhR agonists on patients' monocytes
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during the inclusion visit, baseline, day 1
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Microbiota in AID patients
大体时间:3 months
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Dysbiosis measured by alpha and betadiversity
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3 months
|
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Effect of gut-derived metabolites on inflammatory pathways though cytokine production
大体时间:3 months
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Increase or decrease in proinflammatory cytokines secreted
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3 months
|
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Association of microbiota profile with biological control of the disease
大体时间:3 months
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Correlation between microbiota profiles and inflammation biomarkers (C-reactive protein, Serum A Amyloid, proteinuria)
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3 months
|
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Association of microbiota profile and severity of the disease
大体时间:3 months
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Correlation between microbiota profiles and complications (AA Amyloidosis, Cirrhosis)
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3 months
|
合作者和调查者
调查人员
- 首席研究员:Sophie GEORGIN-LAVIALLE、APHP
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- APHP230035
- IDRCB 2025-A01478-41 (其他标识符:ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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