Host-microbiota Interactions in Auto-inflammatory Diseases (NCT07718555) | Clinical Trial Compass
RecruitingNot Applicable
Host-microbiota Interactions in Auto-inflammatory Diseases
France300 participantsStarted 2026-03-09
Plain-language summary
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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 quest…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stool and blood Gut-derived metabolites in patients with AID
Timeframe: 3 months
2
Stool and blood Gut-derived metabolites in patients with AID