Could the gut hold the key to calming autoinflammatory Flare-Ups?

NCT ID NCT07718555

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study investigates whether gut bacteria and the chemicals they produce influence inflammation in people with autoinflammatory diseases such as FMF, CAPS, and MKD. Researchers will analyze stool and blood samples from 300 patients to measure gut-derived metabolites and assess gut barrier function. The goal is to understand how imbalances in gut microbes might trigger or worsen symptoms in genetically predisposed individuals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to: If links between gut microbes and inflammation are found, this could point toward new ways to manage autoinflammatory diseases through diet or probiotics.
What could go wrong: This is an observational study, not a treatment trial. It will not test any therapy, and findings may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

A20 haploinsufficiency autoinflammatory syndrome cryopyrin-associated periodic syndrome deficiency of adenosine deaminase 2 familial Mediterranean fever juvenile arthritis due to defect in LACC1 mevalonate kinase deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoinflammatory diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could the gut hold the key to calming autoinflammatory Flare-Ups?

What the study statuses mean