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Host-microbiota Interactions in Auto-inflammatory Diseases (HO-MICRO-MAI)

2026年7月17日 更新者:Assistance Publique - Hôpitaux de Paris
Autoinflammatory diseases (AID) are genetic diseases responsible for excessive activation of innate immunity leading to blood inflammation and systemic symptoms. Most patients display digestive involvements that may resemble inflammatory bowel disease. Several studies have found dysbiosis in some AID. Gut microbiota can communicate with the host via gut-derived metabolites (Fatty acids, tryptophan, bile acids) that may have either pro-inflammatory or anti-inflammatory effects. Some metabolites can also activate the Aryl hydrocarbon receptor (AhR) pathway, which enhances gut barrier. Gut barrier dysfunction has already been associated with AID. Therfore, dysbiosis could promote digestive and inflammatory involvements in genetically predisposed patients via perturbations of gut-derived metabolites.

研究概览

地位

招聘中

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

观察性的

注册 (估计的)

300

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Paris、法国、75020
        • 招聘中
        • Internal medicine, Tenon Hospital (APHP)
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

不

取样方法

非概率样本

研究人群

Patients with auto-inflammatory diseases (Familial Mediterranean Fever, Mevalonate kinase deficiency, Cryopyrin-associated periodic fever, A20 haploinsufficiency, ADA2 deficiency, LACC1-associated juvenile arthritis, JAK1-associated autoinflammatory disease, or Syndrome of Undifferentiated Recurrent Fever ) followed up in the French reference center of autoinflammatory diseases.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Patients with autoinflammatory diseases

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
Quantification of gut-derived metabolites in stools using mass spectrometry
3 months
Stool and blood Gut-derived metabolites in patients with AID
大体时间:3 months
Qualitative evaluation of gut-derived metabolites in stools
3 months

次要结果测量

结果测量
措施说明
大体时间
Role of AhR on activation of inflammatory pathways
大体时间:during the inclusion visit, baseline, day 1
Quantification of pro-inflammatory cytokines in presence of AhR agonists on patients' monocytes
during the inclusion visit, baseline, day 1
Microbiota in AID patients
大体时间:3 months
Dysbiosis measured by alpha and betadiversity
3 months
Effect of gut-derived metabolites on inflammatory pathways though cytokine production
大体时间:3 months
Increase or decrease in proinflammatory cytokines secreted
3 months
Association of microbiota profile with biological control of the disease
大体时间:3 months
Correlation between microbiota profiles and inflammation biomarkers (C-reactive protein, Serum A Amyloid, proteinuria)
3 months
Association of microbiota profile and severity of the disease
大体时间:3 months
Correlation between microbiota profiles and complications (AA Amyloidosis, Cirrhosis)
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sophie GEORGIN-LAVIALLE、APHP

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月9日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2026年4月20日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日

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)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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