Gut microbes and autoinflammatory diseases: how they may be linked

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects stool and blood/urine samples from patients with autoinflammatory diseases to explore gut microbiota and metabolites. Participants provide a stool sample with a questionnaire, plus urine and possibly blood samples collected during routine care. Samples are analyzed at the Microbiota, Intestine and Inflammation lab to examine microbial composition and metabolite pathways that may affect gut barrier and inflammation. The study relies on patients and clinicians during standard consultations, with sample shipment arranged by carrier and mail where needed. No experimental interventions are described beyond sample collection and analysis.

Why it matters

Who can join: the full rules

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

Where it's running

• Internal medicine, Tenon Hospital (APHP)
  Paris, France Recruiting

Study contacts

• Principal investigator: Sophie GEORGIN-LAVIALLE — Aphp
• Study coordinator: Sophie GEOGIN-LAVIALLE, MD PhD
• Email: sophie.georgin-lavialle@aphp.fr
• Phone: 01 56 01 70 82

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.