Host-microbiota Interactions in Auto-inflammatory Diseases (HO-MICRO-MAI)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Sophie GEOGIN-LAVIALLE, MD PhD
- 電話番号:+33 01 56 01 70 82
- メール:sophie.georgin-lavialle@aphp.fr
研究連絡先のバックアップ
- 名前:Inès ELHANI, MD
- 電話番号:+33 01 56 01 70 82
- メール:ines.elhani@aphp.fr
研究場所
-
-
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Paris、フランス、75020
- 募集
- Internal medicine, Tenon Hospital (APHP)
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コンタクト:
- Inès ELHANI, MD
- 電話番号:+33 01 56 01 70 82
- メール:ines.elhani@aphp.fr
-
コンタクト:
- Sophie GEORGIN-LAVIALLE, MD, PhD
- 電話番号:+33 01 56 01 70 82
- メール:sophie.georgin-lavialle@aphp.fr
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Patients with autoinflammatory diseases
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stool and blood Gut-derived metabolites in patients with AID
時間枠: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
時間枠:3 months
|
Qualitative evaluation of gut-derived metabolites in stools
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3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Role of AhR on activation of inflammatory pathways
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:3 months
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Correlation between microbiota profiles and complications (AA Amyloidosis, Cirrhosis)
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3 months
|
協力者と研究者
捜査官
- 主任研究者:Sophie GEORGIN-LAVIALLE、APHP
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- APHP230035
- IDRCB 2025-A01478-41 (その他の識別子:ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。