Autoinflammatory DiseasesHO-MICRO-MAINCT07718555
Host-microbiota Interactions in Auto-inflammatory Diseases
An observational study of Autoinflammatory Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Autoinflammatory Diseases
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2026to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Internal medicine, Tenon Hospital (APHP)
Paris, 75020
Sophie GEORGIN-LAVIALLE, MD, PhD, 01 56 01 70 82 ext. +33, sophie.georgin-lavialle@aphp.fr
Inès ELHANI, MD, 01 56 01 70 82 ext. +33, ines.elhani@aphp.fr
About this study
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.
Read the detailed description
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.
- Conditions
- Autoinflammatory Diseases
- Keywords
- Autoinflammatory diseases, Microbiota, Gut
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with autoinflammatory diseases | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool and blood Gut-derived metabolites in patients with AID
Quantification of gut-derived metabolites in stools using mass spectrometry
Measured: 3 months
Stool and blood Gut-derived metabolites in patients with AID
Qualitative evaluation of gut-derived metabolites in stools
Measured: 3 months
Secondary outcomes (5)
Role of AhR on activation of inflammatory pathways
Quantification of pro-inflammatory cytokines in presence of AhR agonists on patients' monocytes
Measured: during the inclusion visit, baseline, day 1
Microbiota in AID patients
Dysbiosis measured by alpha and betadiversity
Measured: 3 months
Effect of gut-derived metabolites on inflammatory pathways though cytokine production
Increase or decrease in proinflammatory cytokines secreted
Measured: 3 months
Association of microbiota profile with biological control of the disease
Correlation between microbiota profiles and inflammation biomarkers (C-reactive protein, Serum A Amyloid, proteinuria)
Measured: 3 months
Association of microbiota profile and severity of the disease
Correlation between microbiota profiles and complications (AA Amyloidosis, Cirrhosis)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start9 Mar 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoinflammatory DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie GEORGIN-LAVIALLE, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718555
- Sponsor's protocol ID
- APHP230035
- Other IDs
- IDRCB 2025-A01478-41
- Acronym
- HO-MICRO-MAI
- Status last verified
- Jul 2026
- First submitted
- 20 Apr 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host-microbiota Interactions in Auto-inflammatory Diseases
- ClinicalTrials.gov ID
- NCT07718555
- Acronym / sponsor ID
- HO-MICRO-MAI / APHP230035
- Conditions
- Autoinflammatory Diseases
- Keywords
- Autoinflammatory diseases, Microbiota, Gut
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with autoinflammatory diseases | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stool and blood Gut-derived metabolites in patients with AID
Time frame: 3 months
Quantification of gut-derived metabolites in stools using mass spectrometry
Stool and blood Gut-derived metabolites in patients with AID
Time frame: 3 months
Qualitative evaluation of gut-derived metabolites in stools
5 secondary outcomes
Role of AhR on activation of inflammatory pathways
Time frame: during the inclusion visit, baseline, day 1
Microbiota in AID patients
Time frame: 3 months
Effect of gut-derived metabolites on inflammatory pathways though cytokine production
Time frame: 3 months
Association of microbiota profile with biological control of the disease
Time frame: 3 months
Association of microbiota profile and severity of the disease
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie GEORGIN-LAVIALLE principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoinflammatory Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie GEOGIN-LAVIALLE, MD PhD (01 56 01 70 82 ext. +33, sophie.georgin-lavialle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool and blood Gut-derived metabolites in patients with AID (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.