The Milieu Intérieur Consortium initiated in September 2012 a 1,000 person population-based study in order to assess the determinants of immunologic variance within the general healthy population "Genetic & Environmental Determinants Of Immune Phenotype variance: Establishing A Path Towards Personalized Medicine (ID-RCB Number: 2012-A00238-35)". The protocol was registered under ClinicalTrials.gov (study# NCT01699893).
1,000 healthy donors
A de novo study-group of 1,000 healthy individuals (1:1 sex ratio) stratified across five-decades of life (age 20 – 70) from French-descent and recruited as per a detailed medical questionnaire has been recruited between September 17th, 2012 and August 8th, 2013. Please read the protocol_milieu_interieur.pdf
- To identify factors (genetic, immunological and environmental) that contributes to the observed heterogeneity in immune responses (individual and population levels).
- To characterize the naturally occurring genetic variability of human response using whole genome genotyping and exome sequencing.
- To determine and measure cytokine/chemokine stimulated by 40 pattern-recognition receptors agonists (PRR agonists) or immune stimuli.
- To characterize commensal microbiota (nasal swab and stools samples) in the study population
- To evaluate the metagenomic architecture of the population based on sequence analysis of bacterial, fungal and viral populations in fecal and nasal samples.
- To associate immune response with nutrition data.
- To associate immune phenotype variance with genetic polymorphisms and enterotype.
- Determination of genotype-to-phenotype associations at a mechanistic level.
Subject recruitment has been stratified by:
- Gender (500 males / 500 females)
- Age - 5 decade strata (200 subjects/decade)
- Age (≥ 20 and ≤ 69 years)
The study was approved by the Comité de Protection des Personnes – Ouest 6 (Committee for the protection of persons) on June 13th, 2012 and by French Agence nationale de sécurité du médicament (ANSM) on June 22nd, 2012. The study is sponsored by Institut Pasteur (Pasteur ID-RCB Number: 2012-A00238-35), and is a single center interventional study without an investigational product. The protocol was registered under ClinicalTrials.gov (study# NCT01699893).