Internal medicine, Tenon Hospital (APHP)
Paris, 75020, France
Location status: Recruiting
Location contact
Inès ELHANI, MD
CONTACT
01 56 01 70 82 ext. +33
Sophie GEORGIN-LAVIALLE, MD, PhD
CONTACT
01 56 01 70 82 ext. +33
NCT Number: NCT07718555
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.
Interested in participating?
Request Info12 year and older
All sexes
Observational
Paris, 75020, France
Location status: Recruiting
Inès ELHANI, MD
CONTACT
01 56 01 70 82 ext. +33
Sophie GEORGIN-LAVIALLE, MD, PhD
CONTACT
01 56 01 70 82 ext. +33
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
Quantification of gut-derived metabolites in stools using mass spectrometry
Time frame: 3 months
Qualitative evaluation of gut-derived metabolites in stools
Time frame: during the inclusion visit, baseline, day 1
Quantification of pro-inflammatory cytokines in presence of AhR agonists on patients' monocytes
Time frame: 3 months
Dysbiosis measured by alpha and betadiversity
Time frame: 3 months
Increase or decrease in proinflammatory cytokines secreted
Time frame: 3 months
Correlation between microbiota profiles and inflammation biomarkers (C-reactive protein, Serum A Amyloid, proteinuria)
Time frame: 3 months
Correlation between microbiota profiles and complications (AA Amyloidosis, Cirrhosis)
Contact information is provided by the study sponsor or research team.
Inès ELHANI, MD
CONTACT
01 56 01 70 82 ext. +33
Sophie GEOGIN-LAVIALLE, MD PhD
CONTACT
01 56 01 70 82 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Acronym: HO-MICRO-MAI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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